Multimodality medical procedure mattress-based device

ABSTRACT

A mattress system is provided that is optimized for the hospital setting and includes a guiderail system that accepts a variety of accessories for attachment thereto. The guiderail system may have integrated data lines, power lines, gas lines, and/or fluid lines. Also provided are radioabsorbant shields, trays and other components designed for optimal use with the mattress system.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 14/961,822 filed Dec. 7, 2015 entitledMultimodality Medical Procedure Mattress-Based Device, which claimsbenefit and priority to U.S. Provisional Patent Application Ser. No.62/088,495 filed Dec. 5, 2014 entitled A Multimodality Medical ProcedureMattress-Based Device, and to U.S. Provisional Application Ser. No.62/240,409 filed Oct. 12, 2015 entitled Radioabsorbent Assemblies, allof which are hereby incorporated herein by reference in theirentireties.

FIELD OF THE INVENTION

The present application relates generally to the use of devices duringmedical procedures (e.g. heart catheterization, surgery, medicalimaging) in which a patient lies on a surface.

BACKGROUND OF THE INVENTION

Patient tables are used in a wide variety of settings for medicalprocedures and for patient transport. In most or all of theseprocedures, the patients lie upon a mattress that rests atop the patienttable and typically consists of a soft pad that is contained within aflexible cover. While on the mattress, the patient is often connected toany one of a number of monitors that may be used to monitor pulseoximetry, blood pressure, electrocardiogram tracings, heart rate orother physiologic information. In addition, medical treatment devices,such as intravenous infusion pumps and cardiopulmonary resuscitationdevices are connected to the patient on the mattress and attached tosurrounding structures, such as a gurney or free standing pole.

The intention of the mattress design is to provide a durable, easilycleanable, relatively comfortable location for the patient to liethrough the procedure with a shape that matches the table upon which itis to be used. This type of mattress is present on all patient tablesthroughout the hospital. While providing some modicum of patientcomfort, this mattress is not designed with any additional features toprovide value to the patient or clinician. In fact, patient mattressesare frequently surrounded by a variety of monitoring and therapeuticdevices that are attached to the patient in one way or another. Thisresults in a confusing array of cables, tubes, power sources, gassources (such as oxygen), and displays. All of these require attachmentto the patient or travel with the patient, creating a complex web ofdevices around and connected to the patient. These connections are proneto inadvertent mis-application and disconnection. Moreover, the need fora battery power supply in some devices increases weight and creates aneed for recharging of multiple devices.

Many of the ancillary medical devices referred to above are attached toa table or gurney that supports the patient mattress. X-ray tables withrails that support patient mattresses have been developed (e.g. PhilipsAllura Centron table) and rail systems for stretchers have beendescribed (applications Ser. Nos. 12/107,730, 11/784,994 [lapsed], Ser.No. 12/651,601). The rails attached to the table prevent patientmovement without moving from the table rails all ancillary equipmentattached to the patient. That impedes patient transfer to a bed andoften leaves the patient unmonitored while electrodes are reattached.

Support structures within mattresses have been described, but these donot protrude from the mattress, are not intended to be attached tomedical devices, and do not carry power or data conductors, or gastubing (U.S. Pat. Nos. 8,984,690, 763,442, 4,676,687).

Mattresses with flexible covering to aid sliding and evacuation ofpatients from hazardous environments have also been described(PCT/IB2011/000190, PCT/IB2011/003057, U.S. Ser. No. 13/452,079, U.S.Ser. No. 12/968,840, U.S. Ser. No. 11/617,061), as well as ones withintegral spinal protection boards within the mattress to stabilize thespinal cord during transport and straps to stabilize the patient withinthe evacuation apparatus. While helpful for evacuation of patients,these products do not support ancillary medical equipment such as pumps,monitoring devices, or radiation shielding.

Stith described a life support bed where the medical equipment neededfor life support reside on the carriage of the bed (U.S. Pat. No.4,584,989). This device obviously could not be easily transported orused for x-ray imaging.

In the medical procedure environment, the mattress and associatedpatient table are two of many pieces of equipment commonly used. Oftentimes, there are monitors for electrocardiogram tracings, pulseoximetry, blood pressure and other purposes. For each of these monitors,there are associated cables or leads used to connect to the patient.These cables often become entangled and there is always a risk thatleads are inappropriately managed or connected to the patient.Challenges with cable management can lead to procedural delays,entanglement with other devices, and potential patient misdiagnosis.

Medical procedures are performed often on patients lying horizontally ona mattress, such as an operating table. Ancillary equipment such asintravenous pumps, control consoles and imaging displays are oftenattached to a side rail on the operating table or bed frame. These railsare composed of metal and are configured to allow the attachment of aclamp or locking mechanism to fix the equipment to the rail. One problemwith this method of attaching medical equipment to tables is that thetable is usually fixed to a rigid structure such as an x-ray unit,stretcher, or large bed. Therefore, when patients are moved, the entireset of control devices and other medical devices attached to the patientmust to detached and reattached to another bed structure or simply heldby a caregiver or the patient. In addition, many of the devices attachedto the rails require electrical power, connections to other devices, orpressurized gas. This creates a clutter of wires and tubes around thebed and also may impede efficient patient transfer from one area toanother.

Another aspect of a patient mattress is the fact that the mattress mustbe thoroughly cleaned after each use. Concerns of viral or bacterialtransmission from patient to patient necessitate an extensive cleaningprocess that includes manual spraying and wiping of all patientsurfaces. Following that process, other potential disinfecting stepssuch as UV light or other sterilants may be used in an attempt to reducethe risk of contamination and disease transmission.

In the instance of a patient table used in an interventionalcatheterization laboratory, there are additional aspects to the use ofthe table and mattress. Arm boards are commonly used to support the armsof the patient, both with standard arm boards during a typicalinterventional procedure as well as with custom arm boards designed tomanage the arm during a radial artery access procedure, in which theradial artery of the arm is accessed for catheterization. The currentstate of the art with these boards is simply to slide a polymeric sheetunder the back of the patient to stabilize the board, which cantileversover the edge of the mattress to support the arms. This can be adifficult maneuver to insert the board, and the rigid board directlybeneath the back and shoulders of the patient may be uncomfortable.

The patient's wrist can be placed in any number of support devices thatlay on the arm board. These support devices generally extend the wristto provide better access to the radial artery. The disadvantage is thatthe support devices must themselves be secured to the arm board. Inaddition, procedures are usually performed with the physician on thepatient's right side. Access to the patient's left arm for radial orbrachial artery access to difficult. Typically, the entire operatingteam has to move to the patients left side and the room monitors (forexample, x-ray and physiologic monitoring) must be moved to the oppositeside. As a result, many surgeons have the patient drape their left armacross their abdomen in order to access the left arm arteries from thepatient's right side. In this position, the surgeon's exposure to x-rayincreases significantly. A number of devices have been developed tosupport the left arm in this position, but none have integrated x-rayshielding. i

In addition to the discomfort to the patient, there is risk duringradiographic procedures to the physician and cath lab staff due toradiation exposure. The fluoroscopy unit that provides imaging duringthe procedure emits x-rays that pass through the patient with the intentof reaching the image intensifier for the image to be transferred to themonitor. However, significant portions of the radiation intended forimaging are scattered by interaction with the patient and spread aroundthe cath lab. Some of this x-ray radiation is ultimately absorbed by thephysician and staff, increasing their overall radiation exposure.

Radiation protection during medical procedures requiring x-rays or otherionizing radiation is a major health concern for health care workers(HCW). There are numerous methods of shielding the HCW from radiation.Commonly used methods include the use of flat, inflexible, clear oropaque shields impregnated or covered with lead or lead equivalentmaterials. These are cumbersome to operate and require constant movementby the HCW to shield themselves from radiation. Frequently, they also donot conform to the patient's body habitus and contours. In addition,shields often get in the way of adequate fluoroscopic visualization ofthe patient or key areas of the patient that require easy access ormonitoring. Another major impediment of existing methods is that the HCWhas to move these heavy equipment manually and also conform their bodiesto visualize around the impediments caused by the existing devices. Thisis a major cause for musculoskeletal morbidity of the HCW resulting inchronic neck, back injuries. Consequently, it is common for the HCW tosacrifice radiation protection for better visualization as well asbetter ergonomics by moving the current shields out of the way orpositioning them in a markedly sub-optimal protection position. Inaddition, many times the HCW forgets to move the shields for adequateprotection.

Systems of radiation shielding have been described. These systems,however, employ extensive heavy shields or encase the operator in arestrictive enclosure.

The device described herein offers continuous and critical radiationprotection by partially or fully automating the radiation protectionprocess as well as providing optimal patient and HCW ergonomics.

The primary problem with prior attempts to provide x-ray scatterradiation shielding is that the shield must conform to the patient'sbody contour and also be able to conform to the x-ray imaging device.Patients come in a wide variety of shapes. X-ray units are bulky and thephysician often needs to image the patient at widely varied anglesrelative to the patient's long axis. For example, cardiac imagingrequires the x-ray camera to be positioned in all four quadrants (overthe left and right shoulder and over the left and right rib cage). Thephysician usually inserts a catheter into a blood vessel at a specificlocation such as the femoral artery, radial artery or jugular vein. Thephysician often needs to stand next to that body part during theprocedure. As a result, an ideal shielding system would be able toconform to both the patient shape and the position of the x-ray camera.

A number of shields have been developed to absorb scatter x-ray. Themost commonly employed is an apron, vest or skirt with integrated x-rayabsorbing material that is worn by the user. X-ray absorbing gloves,glasses, and head caps have been worn to prevent x-ray exposure ofspecific body areas. These devices are cumbersome, heavy, and have beenassociated with orthopedic injuries. X-ray absorbing pads have also beendeveloped (U.S. Pat. Nos. 6,674,087, 7,677,214). Problems keeping thepads clean from patient to patient have led to their use in a disposableform. This adds to medical cost and toxic waste. Finally, fixed, durablex-ray shielding has been used extensively. These devices primarilyinclude leaded glass or acrylic in planar sheets hung from the ceiling,attached to the rails of an x-ray table, or placed into a free-standingstructure (such as a wheeled structure or apparatus hung from theceiling). Cocoons (in which the physician resides while operating) thatabsorb x-ray and large x-ray absorbing barriers have also been described(US20020109107, U.S. Pat. No. 7,091,508). These devices have shown to betoo cumbersome to be of practical use. A number of other fixed or mobilex-ray shields have also been described. They provide partial x-rayprotection for the physician and staff.

One challenge to x-ray visualization in the cath lab is ensuring thatthe area of treatment in the patient is not blocked by radiopaquematerials that prevent adequate x-ray penetration for imaging.Typically, any radiopaque clip, instrument or wiring that is near thepatient will appear on x-ray and potentially prevent visualization ofcritical anatomy. In particular, cables such as ECG leads that may drapeacross the patient can cause imaging difficulty. Many medical proceduresrequire imaging of body parts and simultaneous monitoring of physiologicfunctions, such as an electrocardiogram, blood oximetry, respiratoryrate, and blood pressure. Many conductors of electricity, such as copperand gold, are visible under x-ray and interfere with medical imaging.Even aluminum, which is less visible under medical x-ray, can be seenwhen the wire diameter is sufficiently large or when multiple wires arestacked together, such as when conductors are circled by a shieldingmaterial. These problems interfere with the monitoring of patientsundergoing x-ray examinations.

While there are concerns that clips and wiring may interfere withvisualization of patient anatomy, there is a need for connections to thepatient in a manner that provide critical diagnostic information. Pulseoximetry, electrocardiographic traces and blood pressure readings areall examples of data that may be vitally important during a medicalprocedure. Currently, the methods used to gather this information arenot streamlined or synchronized in a manner that is conducive to simpleand easy use in the interventional cath lab or other medical settings.Solesbee (U.S. Pat. No. 6,721,977) described the use of wires in apatient mattress to allow integration of patient monitoring cables.Wilson and Kim (U.S. Pat. No. 8,491,473) describe a conduit systemwithin a patient mattress, where the conduit carries wires formonitoring and patient treatment. These are useful additions to thepatient mattress, but the conductors and conduits are visible on x-rayimaging when the x-ray camera is turned in some directions (such as whenthe x-ray tube is under the patient's right shoulder aimed at an x-raydetector that is over the patient's left lateral chest). Wiring that isconductive but nearly invisible under x-ray would improve the inventionsof Solesbee et al (U.S. Pat. No. 6,721,977) and Wilson et al (U.S. Pat.No. 8,491,473).

Others have described mattresses of composite construction, includingpossible components such as flexible inner members with a range ofstiffness and an outer containment jacket or cover. However, no presentinvention envisions a mattress of composite construction that utilizesthe materials of the construction to provide for a rigid frame, patientcomfort and a suite of features that may provide solutions to previouslyunresolved issues related to imaging, radiation exposure, cleaning andmodular attachment of arm boards or other devices and monitors.

OBJECTS AND SUMMARY OF THE INVENTION

Aspects of the invention described herein generally include:

-   1. A mattress on which a patient lies, where the mattress is    contained within an outer, more rigid shell-   2. Rails attached to the mattress or mattress shell are used to    attach medical devices and shielding, where the rails may contain a    power supply, medical gasses, and conductors for data and computer    communication-   3. A flexible x-ray shielding system that conforms partially to the    patient and x-ray system independently-   4. A wiring system composed of flat conductors that are minimally    visible on x-ray-   5. A blood pressure cuff that can be applied around the arm or leg    like a clamshell-   6. One or more work surfaces that attach to the mattress rail and    provide attachments for clips and other devices to stabilize    catheters in the sterile field, an inductive power supply to the    sterile field, and radiation shielding-   7. One or more heating elements in the mattress with one or more    surface temperature feedback sensors that can be used to warm    patients in selective body locations or to sterilize the mattress    with heat-   8. An attachment for cardiopulmonary resuscitation that attaches to    the mattress rails and derives power or data control from the rails    or mattress.-   9. An intravenous infusion pump that receives power from the    mattress rails or data control from the mattress or mattress rails.-   10. A capacitive ECG sensor that is imbedded into the mattress cover    or located below the cover and associated electronic signal    processing to provide an ECG signal from the patient lying on the    mattress.-   11. A device to hold the patient's head that provides radiation    shielding, stabilization of head position, and a wrap around the    neck that allows for rapid circumferential cooling of the neck to    provide brain hypothermia.

This invention describes a medical procedure mat designed to provideintegrated patient monitoring and comfort by having a mattress andperimeter shell. The shell is composed of a material more rigid than thefoam mattress supporting the patient, such as closed cell foam, fiberglass, carbon fiber, or other rigid material that has minimal x-rayabsorption, and an inner insert with open cell or more elastic materialto provide comfort. The surface upon which the patient will reside iscovered with either flexible closed-cell foam or another appropriatetextile that is durable and easily cleaned after use. Medical monitoringand connections to the monitoring devices may reside in between therigid and flexible layers.

The invention is an object on which a human can lay or sit, where theobject contains sensors to monitor physiologic functions. In addition,the object may contain therapeutic devices to provide treatment. Inaddition, the device has a variety of compartments to house medicalequipment and a perimeter rail attached directly to the mattress toprovide additional monitoring and therapeutic devices, and a system fordistributing electrical power, medical gasses, computer datatransmission, and radio receivers and transmitters.

In one embodiment, the object is composed of carbon fiber. The carbonfiber supplies sufficient rigidity to support the remainder of theobject, including the included devices and the patient. The carbon fiberstructure has cavities or drawers for storage of devices and wiring(including electrical and optical cables, with optional electromagneticshielding). In addition, the closed carbon fiber may also have rigidmembers within or covering the foam to provide additional structuralintegrity.

In one embodiment, the main cavity of the closed cell foam 1 is filledwith a softer foam 2 for patient comfort. In one embodiment, one or moretop layers of foam are provided to further enhance comfort or to providespecialized functions, such as electrical conductivity, magneticproperties, radiation blocking agents, antibacterial, antifungal orantiviral properties, or photon transmission.

In one series of embodiments, the procedure mat is designed to integratewith commonly used procedure tables that have been installed in thehospital or clinic. In this way, the mat replaces the simple mattressthat sits upon the table with a device that provides for patient comfortas well as patient monitoring and cable management.

In one such embodiment, the procedure mat is a relatively rectangularshell structure constructed of relatively rigid closed-cell foam with anopen top surface. In another embodiment, the shell is composed of carbonfiber. In yet another embodiment, the shell is composed of aluminum.This shell contains a cavity to house an inner mattress component whileacting to provide structural rigidity to the composite device, allowingfor routing of cables or wiring throughout the mat and locations towhich other structural members such as rails or monitors may be mounted.The inner mattress component is a compliant material which provides forpatient comfort. The upper surface of the mat will be covered by aflexible, non-permeable material that will provide for patient comfortas well as furnish a non-porous surface that is impermeable to fluids,resists staining and is easily cleanable.

This profile of this structure may also be adapted to better matchpatient anatomy and provide closer access to the patient from thecaregiver or for diagnostic, therapeutic or imaging equipment. In theseconfigurations, the head region of the mat is narrowed, with the matincreasing in width at the shoulder level and possibly again at the hiplevel on a supine patient. This type of mat configuration and others maybe dimensionally specified to match geometries with procedure tablesproduced for interventional cardiology, radiology, surgery or other use.In another embodiment, the flexible portion of the mat has protrusion orindentations that facilitate the positioning of the patient on the mat,such as a protrusion at the superior shoulder level to guide optimalpositioning of the patient in the long axis of the mat. Similarly,indentations or protrusions for the trunk head, or legs help positionthese body areas in the left-right axis of the mat.

In yet another embodiment of the procedure mat, the mat contains otherfeatures to improve functionality for specific uses. In the regionwithin the mat on which the patient's torso rests, the mat may contain amore rigid support structure that supports the chest of the patient Thepurpose of this more rigid structure to improve the effectiveness ofchest compressions if they are required for cardiac resuscitation.

Another feature of the outer more rigid structure of foam or carbonfiber is the ability to create outer ridges that prevent patients fromfalling off of the mattress. In one embodiment, the outer ridge can byfolded to the outer side of the mattress to allow easier transfer of thepatient of the mattress. Moreover, the hinged segment, once folded over,provides an extended surface for transfer.

The anchoring of components to the mat is deemed beneficial inparticular when considering the range of procedures that may beperformed on a patient residing upon the mat. In the case ofinterventional cardiology, arm boards are often desired to provide alocation upon which the patient may rest their arms. Current technologyuses a rigid polymeric sheet that is anchored by placing it under thetorso of the patient, an unwieldy and uncomfortable environment. Theanchoring component of the mat allows for arm boards 4 made of foam orother material to be designed to be integrated with the anchoringcomponent so that they may be attached or detached as desired. Thisprovides simple, modular and comfortable use of arm boards whennecessary for a procedure.

The resuscitation aspect of the embedded reinforcing structure providesa significant benefit when compared to the current state of the art. Atthe present time, if a patient suffers from cardiac arrest and requiresresuscitation, the physician will initiate chest compressions while thepatient is lying on a standard mattress. The typical mattress hassignificant compressibility, meaning that for each chest compressionapplied by the physician, a substantial amount of the energy goes intocompressing the mattress rather than compressing the rib cage andultimately the heart. The result is less-effective compressions, causinga significantly higher level of fatigue to the physician and reducedcardiac output. By adding a rigid component in place of a portion of themattress under the chest of the patient, the compressibility of the matis reduced. Therefore, the result is more effective chest compressionswhich result in lower physician fatigue and better clinical results.

In addition to the modular arm boards that may be added to the edges ofthe mat, additional components may be added to the mat itself ormodularly added to arm boards that are attached to the mat. In oneparticular embodiment, flexible radiation shields may be reversiblyaffixed to the arm boards on a mat used in interventional cardiology orradiology procedures in such a way that they may extend vertically,horizontally or in a curved manner around the patient. These radiationshields are designed such that they prevent x-ray radiation thatreflects or backscatters from the patient from reaching the physician orcatheter lab staff. Other modular radiation shields may be placed at ornear the waist of the patient and/or near the neck of the patient toprevent backscatter radiation from exiting the imaging field. Each ofthese shields are designed such that they will flex out of the way whencontacted by the image intensifier of the c-arm or x-ray imaging unit asit rotates around the patient.

These modular shields may be designed such that they act independentlyof one another so that movement or use of one component does not affectthe other components. Alternatively, they may be designed to mate withone another such that they are attached to one another during use withclips, snaps or magnets, or their geometric design may be such that thecomponents nest within one another in their static position. In oneembodiment, the edges of the components are magnetically attracted toone another so that they provide continuous radiation protection aroundthe patient through direct contact between the components, but when theimage intensifier pushes on the component the magnetic attractionbetween components is broken and the impacted radiation shield is freeto bend and flex out of the way.

In another embodiment, the winged radiation shield attached to themattress can bend on a hinge, for example a hinge with a spring thatbiases the hinge to a position such that the radiation shield is in anupright position. When an x-ray camera needs to be positioned such thatthe radiation shield would prevent the user from obtaining the desiredradiographic projection, the shield can be reversibly moved aside by themovement of the camera by the shield pivoting on the hinge. If a view isdesired that is more lateral than can be provided by the wing with thespring-loaded hinge, a release mechanism can be actuated thatdeactivates the spring and allows the hinge to rotate completelydownward, moving the wing out of the field of view.

In yet another embodiment, the neck and waist components of theradiation shield are specifically adapted to ensure that vascular accesscan be gained for an interventional procedure. There are notches orcutouts provided in the shield so that the femoral artery and femoralvein may be reached in the leg, and the carotid artery and jugular veinmay be reached in the neck. Additionally, the radiopacity of the shieldcomponents may be reduced in key regions so that areas that may requirevisualization such as the distal aorta and the iliac arteries can beseen through the shield.

In yet another embodiment, the waist component of the device consists ofa “Flag” with elements to conform to patients' body habitus and otherelements to flexibly and reversibly deform to accommodate otherequipment in the environment of the operating room.

The flag consists of an element that attaches the Flag to the patient'smattress, the table the patient lies on, a free standing device or to awall or ceiling mount. The attachment mechanism has one or more rigidarms connected at an angle, such that an arm(s) are horizontal andextend from the Attachment mechanism. Below one of the arms is aradiation absorbing material configured in such a way as to conform tothe patient's body. Above the same or another arm is a radio-absorbingmaterial that can be reversibly displaced. For example, an x-ray cameracan be positioned such that it pushes the upper part of the shield awayto allow the camera to be positioned for a particular x-ray view.

The upper functional unit has a degree of internalflexibility/elasticity and has a horizontal articulation with a lowerfunctional unit and a vertical articulation with a lateral functionalunit. This allows the upper unit to freely move on a horizontal axis aswell as have some elastic stretch when the equipment in the room such asan image intensifier pushes it to enable optimal imaging conditions.This allows the lower functional unit to remain in place on the patientcontinuing to block radiation scatter from the patient's body while theupper unit bends away and conforms to the image intensifier. Inaddition, the Flag can have vertical supports throughout. The supportscontain a hinge or spring apparatus to allow the Flag to bend in thevertical plane. This allows the Flag to conform to other radiationabsorbing material, allowing the Flag continues to form a shell aroundthe patient to continue blocking the radiation scatter. Because the Flaghas elastic properties, when the image intensifier moves away from aninterfering position, the Flag returns to its initial position,preventing gaps in the shielding where radiation may be emitted towardsthe HCW.

In one embodiment, the Flag has asymmetric curves that contour to apatient body habitus in the lower functional unit to maximize radiationprotection to the HCW.

This novel invention contrasts with current devices, which are pushedout of the way by the image intensifier or the HCW to prevent getting inthe way of the HCW being able to work with catheters etc.

The invention allows the lower portion of the flag to stay in placewithout moving away and also adds the ability of the upper functionalunit to continue to offer radiation protection. This combinationminimizes or eliminates the interference to the HCW work flow and allowsthem to continue their procedure uninterrupted.

The third functional unit in the current embodiment includes a contouredlateral unit which has a vertical articulation with the upper and lowerunits of the flag. The lateral unit curves towards the patient to blockthe radiation that currently reaches the HCW due to the wide gap betweenthe floating ceiling-mounted shield and a lateral shield sometimes usedby HCWs. The vertical articulation also allows for the flag to conformwith the lateral wing described previously. In addition, there are alsocut out areas along the lower border of the lateral and lower functionalunits to contour to the patients forearm and the groin area to allow formaximal visualization.

The radioabsorbent barriers on the top or bottom of the Flag can becomposed of multiple overlapping material, such that an objectdisplacing one piece of material would not displace the adjacentsection. This would improve radiation protection.

The flag units can be constructed of radioabsorbent fully or partiallytransparent material or could have a radioabsorbent clear window inportions to allow for optimal patient visualization. The Flag also canhold a patient instruction and or entertainment window where a screencould be placed.

In another embodiment, the flexible portion of upper part of theradiation shield is composed of multiple rigid elements that areattached to the shield with at a hinge. The elements absorb x-ray andcan flex at the hinge point passively as the x-ray detector pushes them.The hinge can be a simple spring hinge that rotates in one plane or aball hinge that rotates in two planes. It is recognized that many typesof hinges could provide a rotating mechanism. An advantage of multiplehinged shields is that only a portion of the shield will be displaced,improving radiation protection of the operator and also reducing theforce needed to move the portion of the shield that obstructs the x-raydetector. An additional benefit is the transparent shielding material,which is inherently inflexible, can be incorporated into the shield.This has the advantage of allowing the physician to see the patientthrough the flexible shield.

In another embodiment, the multiple rigid elements are composed of amixture of flexible and in flexible material. For example, leaded glasscan be combined with a flexible polymer material, such that a portion ofthe individual element is flexible and a portion is rigid.

In another embodiment, the multiple element shield can be attached tothe workbench, such that the element rotate from the workbench, whichserves as a supporting member.

The Flag is anchored to the mattress or patient table, to another freestanding mechanism or to a wall or ceiling with features that allow forrapid stowage. The Flag has freedom to rotate on 3-axes and also hasspring loading mechanisms built in such that it assists the HCW inmoving the flag with minimal use of force and allows for the flag toreturn back to a neutral position or to another position between neutraland extreme flexion or extension to contours to the patient and theequipment in the room as closely as possible.

Invasive angiography and other medical procedures and operations areoften performed on patient lying on support structures known asoperating tables. In some patients, the upper extremities areinstrumented, particularly the radial artery in the wrist. The armusually rests on an arm board that is attached to the operating table.The arm is often abducted to allow better access to the wrist orantecubital fossa. The arm board holding the abducted arm often pivotsaway from the operating table to support the abducted arm.

In procedures where catheters or other medical instruments extend fromthe arm in a caudal direction there is no supporting surface on whichthe catheter or instruments can lie. As a result, the physician eitherholds the catheter manually or drapes it over the operating table bycurving the catheter or instrument. This leads to catheters orinstruments falling off the table or diminishes the physician's abilityto manipulate the catheter or device. The problem is particularlypresent in patients undergoing radial artery catheterization, wheremultiple catheters and guidewires can extend out of the radial arteryfor over a meter in length.

There are support surfaces that attach to operating tables or arepositioned partially between the mattress and the operating table.Although helpful, the attachment point is below of the surface of themattress and the tables must be removed during patient transport. Inaddition, these tables are simple surfaces, some with x-ray absorbingcapacity but no ancillary capabilities to manage the catheters and wiresemanating from the patient or attachment of devices to supply inductivepower to the sterile field.

The invention described here is a generally rectangular table that canbe attached to the procedure mattress, usually by attaching to a rail onthe mattress. One feature of this board is the ability to attach clipsto hold catheters or wire. Another feature is the presence of aninduction coil to transfer power to devices in the sterile field. Yetanother feature is a quick release mechanism. Another feature is amechanism to fold or rotate the table against the operating table toallow for the transport of patients on and off of the operating tableand mattress.

In another embodiment, the outer ridge of the outer shell is hinged suchthat it can be folded over to the outside of the mattress, creating aflat structure that extends from the mattress outward. This flat surfacecan then serve as a table for the physician to use during the procedure.

The ability to clip or hold catheters and guidewires in place wouldimprove procedure safety, free the surgeon's hands for other tasks, andfacilitate faster catheter exchanges over the guidewires. The problemwith clips is that the operating table is typically covered with asterile drape. The drape is loose fitting and moves. To solve thisproblem, two methods are described for attachment of devices to holdwires or catheters. In one embodiment, magnets (such as NdFeB) areplaced at or within the surface, at certain spots on the board. Wire orcatheter holders on the top of the sterile drape mate with the magnets.The holders have either oppositely polarized magnets or a magneticallyattractive material (such as steel or iron). This allows them to holdposition through the drape material. In addition, the use of twooppositely polarized magnets on one side prevents movement further. Inanother embodiment, the clip holder has the magnet and the board hasareas of magnetically attractive material, (either discrete areas,tracks, or the entire board). Alternatively, the wire holder could be asimple magnet or magnetic material that is designed to mate with themagnets embedded within the surface of the patient mattress. Theintravascular device such as a wire or catheter is placed on the drapeatop the magnet, and a magnet or magnetic material covered in a softpolymer such as silicone is placed on top of the wire or catheter. Themagnetic attraction between the two components will apply pressure onthe wire or catheter, and the combination of the pressure and thecoefficient of friction of the polymeric material will prevent movementof the interventional device. The soft polymeric material will alsoprevent damage to the sometimes fragile interventional device.

Another embodiment of a connector from the sterile field to the table isa clip. The clip is typically attached to the table. The opening is wideenough to allow the drape to lie within the clip. A wire or catheterholder then sits on top of the drape. It has a configuration that mateswith the underlying holder, reversibly locking the upper holder toattach to the table.

In another embodiment, an adhesive pad attached to the underside of thedrape or the surface of the table holds the drape to the table. The wireor catheter holder is attached adhesively to the attached drape.

Another embodiment of a clip mechanism that provides for simpleattachment and release may be constructed of a highly compliant materialsuch as silicone rubber or foam with a magnetic component in the base toaffix to the table surface as described above. This compliant componenthas a notch or space in which the interventional device to be held willreside. Manual compression of the edges of the device compress the notchand grip the device. The deformation of the device by the act ofcompression causes clips mounted on either one or both sides of thenon-compressed axis to extend beyond one end of the device and lock thedevice in the closed configuration. The ends of the clips on thenon-attached side of the device extend beyond the compressible componentof the device. Compression of these clip ends lever the locking end ofthe clips and release the compression. In this way, the locking can beeffected using two fingers in compression on the complaint material andunlocking can be effected by using two fingers to compress the clipends. The combination of the use of a simple attachment and releasemechanism and highly compliant materials provide for a highly effectiveand easy to use component that is protective of the potentially fragiledevices used in interventional procedures.

It is recognized that a combination of the attachment mechanisms couldbe used together.

Delivering electrical power to devices in a sterile field has alwaysbeen difficult. Typically, the power is provided by sterile batteries orby a wire that is wrapped in a sterile drape. In this aspect of theinvention, an induction coil is located within the operating table orside table. The induction coil sits in the non-sterile part of the fieldand is attached at one end to a power source and at the other end to thecoil. Typically, the coil is mounted on the table in plane and at ornear the surface of the table. A sterile receiving coil is placed overthe coil, above the sterile drape. There is a mechanism for fixing theposition of the receiving coil relative to underlying coil. Thesemechanisms include: adhesion of the receiving coil to the drape anddrape adhesion to the table, magnetic connectors as described above, andclip connectors as described above.

In another embodiment, the inductive power source is used to control amedical device through changes in the power delivered. For example, thepower to a motor used to drive an ultrasound probe to spin within acatheter can be adjusted to control the rate of spin and the position ofthe ultra sound generating element within the log axis of the catheterin the patient.

A table described above must be able to be moved out of the way in orderfor a patient to get onto the operating table. The table describedherein can be attached through a quick-connect. In addition, it isanticipated that one could fold the table against the operating roomtable side.

Another type of work surface that may be used in conjunction with themattress is a workbench that resides over the patient on the table,particularly over the lower legs of the patient. This device providesradiation protection, improves workflow, provides equipment storage, caneasily be draped with a sterile bag, provides access for vascularcatheter access, and can easily and quickly be removed from theoperating field. In addition, one embodiment facilitates application ofpressure to the body to reduce bleeding.

This device component consists of a horizontal tray that curves downwardon the end facing the operator. The tray is positioned across thepatient's body. The tray is composed of a radio-opaque material thatblocks x-radiation. The radio-opaque material absorbs x-ray photonsemitting from the patient while the patient is undergoing an x-rayimaging procedure. The curve of the tray blocks radiation emitting fromthe side or legs of the patient. The operator radiation exposure istherefore reduced.

The tray is connected to an attachment apparatus to then connect thedevice to a supporting structure (such as a bed or x-ray table). Theattachment apparatus is fastened to the mattress or table that thepatient lies on or a side-rail. A mechanism in the attachment apparatusallows the tray to rotate around the axis of the attachment apparatus,to flip up toward the attachment apparatus, and to tilt with one edge ofthe tray closer or farther away from the patient. The attachmentmechanism itself can travel in a vertical up and down motion to move thetray above the patient and to lower the tray to the patient's body. Thisallows the tray to be positioned across and just above the patienteasily, which allows the device to accommodate patients of differentbody shapes. It also allows for the tray to be removed up and out of theway quickly in case of emergency.

In another embodiment, the tray is a laminar construct with one or morelayers of radio-opaque material and one or more layers of material withminimal x-ray absorption. In another embodiment the tray is composed aclear x-ray absorbing material such as a clear plastic polymer with ahigh content of an x-ray absorbing material (such as boron, beryllium,barium). In another embodiment, the tray has attachments that do notabsorb x-rays, such as a piece that connects to the attachment apparatusand the tray. In another embodiment, the tray has a forward edge thatcurves upward to more comfortably rest against the patients belly tofurther block radiation from the body.

In another embodiment, the tray is attached to a free standing device.

In another embodiment, the dimensions of the tray are adjustable to fitdifferent patient sizes. Since the tray is connected to an attachmentdevice, the distance between the attachment device and an anatomicallandmark (such as the femoral artery) needs to be adjustable so that thefunctional aspects (such as the cutouts for access to the femoralartery) can be located over the appropriate body location. Additionally,the tray functional aspects might need to be placed over two or morebody areas. The tray can also have multiple sliding or rotatingadjustable surfaces o fit the body dimensions of the patient. Onmechanism is one or more sliding elements. Another mechanism in arotation of two elements on a swivel hinge.

The tray has cut outs to facilitate access to parts of the body, such asthe femoral artery and vein, while minimizing x-ray transmission. Inaddition, radio-opaque flaps or barriers attached to the access sitescan be opened and closed to allow access when the x-ray is off. Inaddition, ridges near the access site block x-ray photons that aredirected at the operator's position.

The tray has attachment devices to hold sterile surgical instruments,imaging devices, or supplies. These attachments allow the operator tohave free hands for other tasks, such a puncturing an artery while theattachment holds an ultrasound probe to visualize the artery through theskin. In one embodiment, the attachments are connected to the trayunderneath the sterile barrier or surgical drape and in anotherembodiment, the instruments are attached over a sterile barrier orsurgical drape.

The tray also has indentations that provide storage areas for surgicaldevices and supplies, such as needles, guidewire attachments, gauze,suture, and sterile fluids. In addition, the tray has spring clips andother attachment devices to hold catheters and wires emanating from thebody. This stabilizes the positions of the catheters or wires and freesup the operators hands.

A light may be attached to the tray illuminates the surgical area. Thelight may be controlled by a switch on the tray or by a remote device(such as a wireless device). The light can provide general lighting tothe procedure area or a focused light on a particular area of interest.The lights are often dimmed in the x-ray imaging rooms and white lightcan interfere with the operators viewing of procedure monitors. In oneembodiment, lights of different colors are used to provide lighting thatoptimizes the viewing of x-ray and vital sign monitors.

In another embodiment, advantage is taken of the position of the trayover the body. During some types of surgical procedures, pressure needsto be applied to the body, for example, to stop bleeding or compress ahematoma. This can be challenging when the bleeding occurs next to thesurgical site. The operator needs to be manipulating catheters orsurgical devices and cannot press on the body at the same time. Anassistant's hands in the field obstruct the operator's hands. A balloonor active device under the tray can be inflated or activated to producepressure on the body. When a balloon is employed, the balloon can beinflated by an electric pump, a manual pump operated by an assistantoutside the sterile field, a manual pump pumped through the drape by theoperator. Alternatively, a simple broad foot can be extendedmechanically (such as a ratchet mechanism) down from the lower surfaceor side of the tray and mechanically locked into place.

Other balloon compression or mechanical compression devices exist. Aballoon device is employed in a band that surrounds the patient.Mechanical C-clamps are used with one portion of the C-clamp under thepatient and a compression foot is over the body. These devices aredifficult to employ during a sterile procedure and require contact withthe posterior and anterior aspects of the patient.

A key feature of this device is that it is used during sterileprocedures. The asymmetrical connection to the attachment device permitseasy draping with a sterile pouch or cover that covers both the upperside of the tray (where the gloved operator touches) and the lower sideof the tray that meets the patient's sterilely prepped skin or thesterile drape covering the patient. In an alternative embodiment, theentire tray is delivered sterile and attached to the attachmentmechanism by a gloved operator. In yet another embodiment, theattachment mechanism and the tray are sterile and are attached to themattress, rail, table or freestanding device by a globed operator.

Another embodiment includes a dedicated mount that attaches to the bedor tray, to which an IV pole or other device (infusion pump, etc) couldbe mounted. The device has flexibility of position so that it can bepivoted to multiple positions or otherwise moved out of the way ifnecessary.

Devices are described that are usable to attach a catheter, wire, orother medical device to an operating table. The device has an attachmentmechanism whereby the holder can be affixed to a drape or operatingtable (with or without a sterile drape), as described above. The holderis type of clip device, where the inner surface of the clip is coveredwith an elastomeric material or a material treated to facilitateattachment to a medical device by a friction fit. On example of anelastomer is a foam material. Another is silicone. Another is a gelmaterial. An example of a friction enhancing material is silicone,certain rubbers, and materials where the surface is treated. Surfacetreatments include grit, ribs and grooves.

Measurement of blood pressure in a clinical environment typically isdone using a cuff that surrounds the arm and a pressure gauge. The cuffcontains an air bladder that can be reversibly pressurized using a pump.The air bladder is connected to a pressure gauge. The cuff containingthe air bladder is typically a strip a long rectangular shape that canbe wrapped around a arm or leg and fastened with a variety of fasteners(such as Velcro, hooks, or buckles) to approximate the air bladder tothe size of the arm. The air bladder is typically pressurized to a levelthat arterial blood flow to the arm is obstructed by the pressure of thebladder encircling the arm. As the pressure is let out of the bladder,blood will flow into the arm intermittently when the encircling pressurefalls below the systolic blood pressure. Flow will become continuouswhen the pressure falls below the diastolic blood pressure. Theoccurrence of intermittent and continuous flow can be determined usingseveral methods, most often by listening for Karotkoff sounds using astethoscope or using the oscillometric method.

One problem with the measurement of blood pressure using a cuff is thatthe cuff must be placed circumferentially around the arm. This requiresthe person applying the cuff to use two hands to apply the cuff to thearm. In addition, creating a cuff that automatically attaches to the armhas been difficult.

Provided is a clamshell-like device containing an air bladder thatreversibly attaches to the arm or leg. The advantage of the device isthat a blood pressure cuff can be attached easily using one hand,without the need to circumferentially wrap the bladder around the arm orleg. In addition, the clamshell device can be attached to a surface andprovide an automatic attachment by the motion of the arm into the openclamshell. The force of the arm into the clamshell activates the closureof the clamshell by mechanical means or by triggering a switch thatsecondarily cause closure (such as using a motorized closure).

Factors that affect pressure measurement by the oscillometric method arethe housing around the air bladder, the completeness of the encirclingair bladder, and the elasticity of the encircling air bladder. Intesting, it was found that a rigid outer constraining device causes morediscomfort and changes the oscillatory changes in pressure relative tothe blood pressure. In one embodiment of this invention, the outerhousing of the air bladder is a rigid hemi-cylinder and interposedbetween the rigid outer housing and the air bladder is an elasticmaterial that is compressed as the air bladder is pressurized. Thisallows the airbladder to pulsate as the pressure is reduced to less thansystolic, but higher than diastolic pressure during blood pressuremeasurement. The material could be a foam or could simply be an air voidwhere the bladder is attached to the rigid structure along its edges.

The two edges of the encircling housing may be attached securely inorder to apply circumferential pressure to the limb. One method offixing the clamshell into a closed position around the arm is to employa spring mechanism, biasing the clamshell in the closed position. It wasfound that this type of configuration had two drawbacks. First, thespring constant required for effective closure was very high and posedproblems for a user to open the clamshell with one hand. Second, thespring altered the oscillation of air bladder pressure relative to theactual blood pressure, making measurement of blood pressure lessaccurate. Closure of the clamshell at the parting line was much moreeffective. This can be accomplished using a number of methods, such as amagnetic attachment, a hook or clasp, a releasable ratchet mechanism, ora pin and receptacle releasable lock. In one embodiment, the attachmentand release is performed with one hand.

The housing for the air bladder may be composed of a rigid shell, suchas a metal or polymer. This provides the easiest manipulation of thedevice. Alternatively, the outer housing can be made from a flexiblematerial (such as cloth, polymer, or foam) with a support skeletoncompose of a more rigid material, such as steel, nitinol, or rigidpolymer. In another embodiment, a rigid foam material can be usedwithout the need for internal support. The advantage of this embodimentis that the inflation of the bladder causes less discomfort.

In one embodiment, the clamshell device is attached to a medicalprocedure mattress, arm board, chair or other surface. In one aspect ofthe embodiment, the air tubing to connect the air bladder with thepressure gauge is integral to the surface on which the cuff is mounted,that is, the tubing is attached to the mattress arm board or chair, orin a channel within the supporting devices.

In another embodiment, tubes emanating from the airbladder attach to thesupporting structure by means of a valved or non-valved plug-inconnection.

In another embodiment, the parting line is not closed for themeasurement of blood pressure (FIG. 4d ). The clamshell is bias-closedby a spring type mechanism (including a spring or compressible airreservoir). A sensor measures the angle at the hinge point of theclamshell, which can be converted to a cross-sectional area described bythe inner diameter of the clamshell. The pulsation of blood in the limbwill cause the angle to fluctuate. In another embodiment, a detector canbe mounted on the parting line to detect fluctuation in clamshelldimensions. A Hall Effect sensor is an example. Another example is alaser sensor to detect distance.

In another embodiment, the distance between two levers attached to theclamshell measured by any of a variety of means (such as a laser)measured over time describes the change in clamshell cross-sectionalarea. An air bladder in the clamshell is inflated until the inner crosssectional area no longer fluctuates because the inflow of blood hasstopped. As the air bladder increases in size, the clamshell is expandedopen against the spring type device near the hinge point, increasing thenearly circumferential pressure around the limb until blood flow intothe limb ceases. The pressure in the air bladder is then reduced slowly.When the fluctuation in clamshell dimensions appears, the pressure inthe air bladder is assumed to be the systolic blood pressure. As thepressure is reduced further, there will be a reduction in pulsation asthe blood flow becomes continuous when the pressure in the bladder isless than the diastolic pressure. This will be the diastolic bloodpressure, which can be displayed. In another embodiment, there is no airbladder. Instead, the spring pressure is increased to increase theclosing pressure of the clamshell. The spring pressure can be increasedby a number of mechanisms. For example, the spring can be turnedmanually or using a motor to increase spring tension. An air bladder canbe inflated under or over the spring. Electromagnetic force can beapplied by energizing a magnet or bringing it into opposition with anoppositely polarized magnet. Alternatively, a constraining cable can beplaced on the spring and the length of the cable (or constrainingdevice) can be increased to “unleash” the closing force of the spring.

Patients undergoing medical transport or procedures often lie on amattress. Described above is a mattress with cabling where medical wiresor other sensor conduits are routed through the patient mattress. Thespecific type of monitoring equipment needed for individual patientsvaries from person to person. In addition, the site of attachment mayvary from person to person. For example, the blood pressure may be takenfrom either arm or leg, depending on the patient's injury or anatomy.Similarly, a pulse oximetry may be attached to the fingers, toes, earsor other body parts. Electrocardiographic leads may be attached from 2to over 12 locations.

Herein described is a medical device consisting of a support structurethat patients can lie, sit or stand on, where there are multipleattachments for sensor leads, such as electrocardiogram leads, pulseoximeter leads, ultrasound transducer wiring, or blood pressure cuff airtubing channels. In this invention, the leads can be reversibly attachedfrom one or more of two or more ports, such that the unattached portswill be automatically inactive by virtue of the receiving port nothaving a sensor input attachment.

In the case of a blood pressure measurement system, at least two portsin the support structure are available for sensor attachment. Forexample, in an oscillometric method blood pressure cuff the sensor isattached to a pressure gauge by tubing so that the oscillation inpressure in the cuff can be measured and the blood pressure can becalculated. Since the blood pressure cuff could be attached to the rightor left arm or leg, it would be advantageous to have a receiving port atmultiple points in the support structure. An open tubing system withmultiple openings would vent the system to ambient air pressure,eliminating the signal from the air bladder in the blood pressure cuff.A one end the tubing is connected to the air sensor. At the other ends,the tubing branches into multiple outlets. In the first embodiment, avalved system is provided which is bias-closed, whereby the insertion ofthe tube from the blood pressure cuff into the receptacle opens thevalve and connects the cuff bladder to the sensor. The other portsremain closed because of the bias-closed valves. In one embodiment, thevalves are passive. In another embodiment, the valves are active, suchthat opening of one valve closed the others. The active valve can bedriven by electricity and can communicated with each other wirelessly orby conductors.

One potential problem with the tubing system connected multiple ports isthat the air volume of the tubing system increases. That could makeoscillometric blood pressure detection more difficult. The problem issolved by creating an internal valving system that closes the unusedports from the main tube to the sensor, unless the receiving port isactivated. The connection between the active receiving port and theremainder of the tubing system can be accomplished by fixed wire orthrough a wireless signal. In another embodiment, all tubing leadsdirectly to an individual sensor such that the tubing is notinterconnected and where the presence of an oscillating air pressure issensed and the sensor is activated.

In an alternate method, the system may be valved so that all tubinglines run through a multi-port rotational valve. This valve may becontrolled so that only one pressure cuff may be activated at a time asthe others are shut off. Orientation of this valve may be manuallycontrolled, or automated by sensors that indicate which port is in useto select valve orientation.

Patients undergoing a variety of medical procedures have electricalcurrent passed through the body for diagnostic or therapeutic purposes,such as defibrillation of the heart, electrocautery for surgery, orradiofrequency ablation of tissue for heart rhythm problems. In mostcases, a ground wire is attached to the patient. The wire is usuallymounted to a broad conductive member and coupled to the patient using aconductive gel. In this invention, a conductive element is describedthat is integral to the procedure mat, such that no additional ground isrequired. The patent is coupled to the ground upon lying on sitting onthe device.

Similarly, electrodes for an electrocardiogram or electroencephalogramare attached to the skin using a conductive gel and adhesive agent.Electrodes may be imbedded into a part of a procedure mattress, chair orhead covering, whereby the coupling occurs without the need for externalwires or cables. In an alternative embodiment, the electrical signal issensed using capacitive leads that are integral to the mattress, chairor head-covering. The leads are connected to a monitoring device ordisplay by mean of a cable that attaches to the mattress, throughradiofrequency or other forms of wireless transmission, or where themonitoring device is a part of the mattress.

In another embodiment, the mattress is foldable. The foldable mattresswill facilitate its use in emergency patient transport where the rescuercan rapidly transport the mattress to the patient's location, unfold it,and immediately obtain physiologic information from the patient andbegin to apply therapy.

Therapeutic hypothermia has been used to improve the outcome of patientssuffering cardiac arrest or circulatory collapse. By slowing metabolismand oxygen consumption, organ salvage and survival is enhanced. Oneproblem is that cooling in the field has been difficult and cooling inthe hospital is often delayed by the time it takes to apply the coolingequipment. In addition, cooling of the brain, an essential organ veryvulnerable to hypoxia, is slowed by the skull, which is a heat sink. Ahead apparatus is provided with one or more thermistors to sense thecutaneous temperature of the skull. In addition, the body of theapparatus contains one or more cavities. The cavity(s) are connected toa pressurized gas reservoir and an exhaust canal. A pressured valve canbe actuated, whereby the pressurized gas flows into the cavity(s) anddue to the rapid pressure fall, the cavity is rapidly cooled.

In one embodiment, the thermistor(s) control the flow of gas to thecavity(s) individually or together by use of a feedback loop, wherebythe gas is controlled to achieve a set temperature. This will preventfreezing of the scalp while achieving maximal cooling. In anotherembodiment, a thermistor sensing core temperature would also providefeedback to the regular valve(s) to reduce flow when a set level of coreor brain temperature was achieved. Core temperature thermistors can belocated in the rectum, blood vessels, ear canal (as a tympanic membranesensor), and eyes (as a retinal temperature sensor, esophagus or otherlocations.

In another embodiment, the head covering would also cover the neck. Theneck contains the blood vessels leading to and coming from the brain.Cooling the neck to aid in brain cooling.

In another embodiment, the gas flow chambers could be perfused with achilled fluid, with similar controls by the thermistors feedbackloop(s).

A guiderail is described that attaches directly to the patient mattressrather than its supporting structure. This guiderail allows forequipment to be fixed to the mobile mattress, so that when a patient istransferred from table to table, the mattress may be moved along withthe associated equipment without the need for shifting leads ormonitors. In one embodiment, the rail itself contains electrical power,pressurized gas, and data communication/control access that can beaccessed through attachments to the rail. This allows the development ofancillary devices that need not have large batteries or connections toelectricity through a long cable to a point outside the operating tablearea. Moreover, creating a common standard for electrical power (forexample 24 volt direct current) would help standardize medical devicesattached to patient care beds. The access to data communication cableswould allow for control of remote devices or remote control of devicesmounted to the rail.

It is anticipated that this rail attached to the mattress may havecommunication with the mattress either through a dedicated bridge orthrough the structural attachments to the mattress. The mattress bodycan contain electrical power source from a battery, generator orconnection to a power source outside the mattress. Typically suchconnections are direct current. Power outlets located on or near therail provide a place for the connection for a variety of medicaldevices, including a heart pump, resuscitation devices (such as a devicethat administers chest compression), a defibrillator and intravenousinfusion pumps. In addition, computer processing units located in therail provide the electronic means of signal processing for physiologicsignals, control of medical devices within or attached to the mattress,and for routing of electronic or optical signals in the rail ormattress. An advantage of placing the processing units in the rail isthat they are easily accessible, they can have control surfaces on therail, and there can be an associated battery in close proximity in therail.

Similarly, the mattress can have a supply of gas within the mattressbody or a supply of gas from a source outside the mattress. The gassource is within the bed mattress, within or attached to the rail, orfrom an outside source that attaches to the rail by tube or otherconduit. The outlet for the gas is also positioned on the rail. Examplesof outlets are simple nipples for attachment of tubing and quick connectvalving. Control of gas flow occurs either at the outflow site, theinflow site or within the rail using standard regulators and gas controlvalves. In one embodiment, the valving apparatus is controlled by amotor or magnets and can be actuated wirelessly or using a control cableto a remote switch within the rail.

Data communication for the cable attachment in the rail can betransmitted wirelessly to a control unit not on the rail through atransmitter in the rail or to the mattress (by wire attached to themattress or wirelessly). In another embodiment, power and data cablecould be directly attached to the rail from an outside source (such ashospital line current with or without a power supply and isolationsource), or hospital computer network, or directly to a device notmounted onto the rail. Additionally, data transmission between devicesmounted on the rail can be communicated though the rail communicationsystem.

It is also anticipated that the rail would be used to help people ormachines transfer patients from one supporting structure to another. Inparticular, the rail can be designed such that it mates with anautomated patient transport device, where the mechanical attachment ismatched to the transport device configuration. In addition, it isanticipated a wireless radio signal or signals, or other positioningapparatus (such as a magnetic field), or a radiofrequency identificationdevice (RFID) located within the rail or attached mattress couldfacilitate localization of the mechanical attachment of the transportsystem to the mattress and the identification of the specific mattress.The geometry of the mattress rail may be such that it allows for quickconnection and disconnection of monitors or other equipment.

In this invention, a system is described for providing radiationprotection of the personnel in the room of a patient undergoing aradiographic examination. X-rays directed at and through patients formedical procedures (such as angiography, transcatheter therapy, andorthopedic operations) cause backscatter radiation as the x-rays aredeflected by the patient's bones and tissue. This backscatter radiationis hazardous to personnel in the environment. Shielding systems havebeen developed for personnel, but they have significant drawbacks thathave limited their use or effectiveness. Wearable body shields are heavyand only provide protection of the covered body parts. The arms, lowerlegs, head and neck are often exposed. Skull caps and glasses havelimited effectiveness. Fixed shields mounted to x-ray table or theprocedure room ceilings are bulky and inconvenient. Although the abovedescribed shielding systems such as wearables or fixed shields arecommonly in use, there are only a few systems that address personnelexposure by efficient anatomic shielding of the patient's body. Theseinclude mats of various size that are positioned on some parts of thepatient's body to reduce scatter radiation. However, these disposablemats offer limited scatter protection, frequently fall of the proceduretable during table or patient movements and are impractical to use tocover large areas of patients anatomy.

Shielding has been limited somewhat by the need to move the x-ray tubeand detector all around the patient in order for the physician toexamine the body from different angles. Here, an x-ray shielding systemis described that is comprised of an elastic member with radiationattenuating properties that is mounted to or on the table or proceduremat the patient is on, such that the system can easily be pushed asideby the x-ray system.

In one embodiment, the system in composed of a foam material, with orwithout a support layer to allow shape retention in its natural statebut allow distortion with minimal force. The foam is loaded withradiation attenuating material, such as BaSO4 or boron species.

In one embodiment, the radiation protection shield is attachedreversibly to the arm board of the patient table or mattress. In anotherembodiment it takes the form of a drape over the patient with areflecting member that rises in a vertical manner. The combination ofthese two embodiments provides a radiation blocking box around theradiated area, such that the operator located inferior to the patient'sshoulders would receive less radiation backscatter.

In another embodiment, a radiation attenuating shield is integrated intoa roller mounted along one side of the mat or procedure table, rail oranother object adjacent to the patient. A plurality of rollers isenvisioned of multiple widths and radiation protecting characteristicsto be used to cover various parts of the patient's body. In oneembodiment, once the patient is positioned on the mat or proceduretable, the radiation shields at the appropriately desired levels arepulled over the patient's body. The free edge of this roller sheet isexpected to mate with the opposite side of the mat or table or rail oranother object adjacent to the patient via a securing mechanism thatcould include magnetic contacts or hooks or another mechanism that wouldbe easy to detach intentionally. These rollers could vary in widthdepending on the patient's anatomy, such that a wider band might coverthe patient's limbs and abdomen and a narrower band might be used inother areas such as the neck. The rollers also could be orientedhorizontally or in a vertical or oblique plane such that they couldeasily be pulled over the patient and also easily retracted at the endof the procedure or also during the procedure if a need arises tovisualize areas covered by the roller. In another embodiment, theradiation shields have areas of differential radiation attenuationcharacteristics. Areas of minimal or low radiation attenuatingproperties over portion of the body expected to be required forvisualization and adjacent areas on the shield that have high radiationattenuation properties for areas of the body that generally do notrequire visualization during the procedure. This ability to customizelevel of attenuation offers the advantage of achieving higher degree ofscatter radiation protection than currently being used in clinicalpractice. In addition, the radiation shields could have openings locatedin certain areas to allow the operator access to areas of the patient'sanatomy (such as the femoral artery for percutaneous vascularprocedures). These openings when not required could be covered byradiation attenuating flaps or another similar mechanism that wouldallow easy repositioning to create openings in the radiation shields.FIGS. 1 and 2 show two versions of the radiation protection offered bythe roller system. In one embodiment of application of these rollers, apatient is positioned on the mat with the operator performing a cardiacprocedure. The roller is deployed to cover the patient's abdomen andshows two circular openings for accessing the femoral artery. Thedetachable flap over the right opening is removed and the operator isusing this opening to access the right femoral artery, the left openingoverlying the left femoral artery has a radiation attenuating flap inplace that has not been removed.

In another embodiment, the operator is at the head end of the patientperforming a procedure which requires access to the heart from the neck.There are two vertical rollers and a horizontal roller that cover theright and left chest and upper abdomen while leaving the access area andarea of the heart requiring visualization exposed. This detachableroller system also has the advantage of being brought into use outsidethe sterile field and applied to offer highly efficient radiationprotection by customizing the areas of the patient's anatomy that wouldrequire to be seen by the operator while eliminating or drasticallyreducing the radiation from the patient's anatomy that does not requireto be visualized.

In another embodiment, there is a hollowed outer member of roller sheetand a separate radiation attenuating mobile inner member that could beextended and retracted into the outer member based on the extent ofradiation protection coverage required by the operator. In oneembodiment shown here, the outer member of the roller is drawn acrossthe patient's abdomen and pelvis, but the radiation attenuating innermember is only extended over the right half of the abdomen and pelvis asthe operator is accessing the left sided femoral artery. Once the needfor accessing the artery is completed, the operator can fully extend theinner member to provide complete radiation attenuation over the abdomenand pelvis for scatter protection. The inner member can be moved insidethe outer member via various mechanisms. One such embodiment envisionsthe inner member to have magnetic properties such that it could easilybe moved forward or backward in the outer member by application of anexternal magnetic force. Similarly, the inner member could also beextended via a motorized fashion. This system offers the advantage ofbeing able to not break the sterile shield but at the same time offercustomizable radiation protection by mobilizing the inner member.

In another embodiment that there could be a spring-loaded roller sheetthat can drop down from the table to the floor and can be pulled back inas needed to get out of the way of the X-ray apparatus.

Cleaning of the radiation shields housed in the rollers is required tobe able to reuse them and to prevent the potential spread of infectiousagents from one patient to another. One embodiment envisions theapplication of UV C light housed in the opening of the rollers such thatthey would sterilize the radiation shield as it is rolled in or out ofthe housing before and or after each use. The UV C light wouldsimultaneously be directed to the top and bottom surfaces of the shieldwhile it is rolled into or out of the housing. Another embodimentenvisions use of a sterilizing liquid in the roller housing.

Electrocardiogram leads are typically connected to a patient at specificlocations on the body. In the most common ECG, a total of 10 leads areconnected to the body, six of which are at specific locations on thechest, defined by anatomical landmarks (specifically, the sternum, ribsand clavicle). Typically, a disposable conductive patch is adheredreversibly to the patient's skin in each location desired for leadattachment. A conductive lead is then attached to the patch by a varietyof mechanisms, including snaps and clasps. Attachment of wire leads tothese location is clumsy and prone to error because the wires can beattached to the wrong leads. In addition, the labor of attachingmultiple leads adds to cost.

Previous solutions described include integrating all the electrodes intoone single larger strip or a pad like structure which is then attachedto the patient's body as a single piece with integrated cable or leadconnections to minimize connection errors and also ease placement.However these systems have not gained much acceptance as they are largeand unwieldy or do not overcome the problems posed with pooradhesiveness of the patches to the patient's body or fully account ofvariations in patient's anatomy (such as the need for multiple sizes toaccommodate for smaller or larger patients or needing to alter electrodeplacement to individualize for patient anatomy).

Described are methods for attaching leads using a disposable conductivepatch placed on the skin of patients at the location desired to have anECG lead and a roller similar to that described for radiationprotection, where the inner surface of the roller contains a grid ofelectrically conductive material that is attached to an electricallyconductive pathway to an ECG machine or to an electronic processingunit. In one embodiment, electrically conductive patches would adheredto a patient's skin at the points where an ECG lead is desired(typically, left and right arm, left and right leg, and six leads on thechest). A conductive gel with a surrounding adhesive material on theskin side is one type of conductive patch. The rolled lead array has afirst end that is rolled on a spool and a second end that can be pulledto unroll the lead array from the spool. The rolled up lead array andenclosure are typically located to the patient's right or left andaffixed to a fixed object, such as a table rail. The second end isunrolled across the chest or body. The second end is attached to a fixedobject on the other side of the patient, typically the opposite tablerail. The roller has areas of conductivity (such as a layer ofelectrically conductive metal or polymer) that are closely spaced. Eachconductive areas (or cells) are connected in an isolated track that maybe electrically shielded by a second or third layer of conductivematerial. The other end of the roller sheet could be secured to theopposite end of the table or could be envisioned to have some weight orspring force which allows it rest on the electrodes while providing themild compressive force to secure them. Alternatively there could be amagnetic attachment mechanism between the electrodes and the cables.

In one embodiment, an opposite end of the tract is connected to anelectrical processing unit. The electrical processing unit (EPU) detectsif the cell of each lead is substantially in electrical contact with thebody, which occurs when the cell is placed into contact with a chestpatch that is conductive. Electrical contact of each cell is detected ifthe cell has a fluctuating voltage consistent with an ECG signal.Alternatively, the resistance between the lead and a ground leadconnection to the patient can identify a cell that has electricallyactive contact. The electrical processing unit, then determines theidentity of each lead by an algorithm using the cells position on theroller grid. For example, the right arm chest lead is always the leadmost to the patient right upper side. Lead V1 is the next lead to theleft at mid position on the grid, and so on. The identified leads arethen routed to the appropriate lead connections on the ECG processingand/or display device.

It is anticipated that more than one cell could be in contact with aconductive pad. In that case, the EPU would group signals from adjacentpads that were in substantial electrical connectivity with the body.Alternatively, the cell with the greatest voltage fluctuation, lowestresistance to the ground, or other connection detection method could beselected as the primary or only lead cell used in the contiguous area.

The roller sheet can be spring loaded, similar to a window shade. Theroller sheet is connected to the display system using standardconnections or wirelessly. The system can be modified to includeradiolucent electrodes and radiolucent integrated leads in the rollersheet for applications that require the use of the EKG monitoring inprocedures requiring the use of x-rays. One example of radiolucent leadsis a radiographically homogeneous grid, such as an aluminum foil or afabric or loymer loaded or coated with conductive material.

It is also anticipated that the roller lead array could be combined withstandard ECG leads wired to the patient.

In another embodiment the roller sheet has an integrated stretch ormotion sensor that monitors respiratory rate and quality of therespiration or change in quality of the respirations based on theexcursion of the patient's chest wall or via an acoustic sensordetecting air flow through the airways. Operator could be alerted whenthe patient might be breathing too slowly, rapidly, too shallow orhaving apneic spells.

Most modern x-ray units have what is referred to as automatic brightnesscontrol, where the x-ray dose (in terms of photon number and energy) iscontrolled by a feedback loop from the detector to the x-ray source,such that the dose is increased to provide a set level of x-rayintensity at the detector. The importance of this is that elements inthe x-ray field that homogeneously absorb x-ray may not appear visibleto the operators. Therefore, a radio-opaque electrical conductor thathomogeneously covers the radiographic field would appear to be invisibleto the operator. If that material was interposed between the x-raysource and the patient, the dose to the patient would be unaffected.

Conduction of electricity in a conducting agent occurs more on theperiphery of the conductor than in the core (the so-called “skineffect”), especially when high frequency electrical signals areconducted. Therefore, maximizing the ratio of the conductor surface areato the total cross-sectional are could be advantageous. The inventiondescribed here incorporates the principles of homogeneous conductorswithin the x-ray radiographic field that have a very flat profile whichresults in low radio-opacity and a very high surface area tocross-sectional area ratio. Additionally described is a simplemanufacturing method to make a set of shielded conductors with thedescribed attributes. These conductors are used to conduct signals formedical monitoring. They are nearly invisible to x-ray imaging and carryhigh current load with wire bandwidth.

Thin aluminum strips increase the surface area/cross-sectional arearatio and the “skin” effect for conduction. Aluminum strips (typicallyless than 0.003 inches thickness) and of any width, but typically 2-10mm, are mounted onto a radio-lucent insulating material. The material isapplied to both sides of the strips. When shielding is required, asecond layer of thin aluminum material (typically less that 0.003 inchesthickness) is mounted onto each side of the insulated strip. The shieldsare connected to provide a 360 degree shield. Multiple conductor ribbonscan be mounted in parallel to the insulating layers. The insulatinglayers can be joined between each conductor or left open, whereinsulation between conductors is obtained by lack of contact due to thefixation to the insulating material. Similarly, the shield can beconnected on the sides of each conductor or only on the sides of theconductor ribbon array.

The conductor starts with a sheet of foil, typically less than 10thousandths of an inch thick. The conductor may be aluminum because ithas less radio-opacity, although any conductor would suffice (such ascopper, iron alloys, gold, platinum, conductive polymers, andcarbon-based conductors). The roll of foil is divided along its longaxis into conducting tracts by cutting the foil with a knife, laser orother means. The tracks are separated slightly and mounted onto anon-conductive material, such a polypropylene. This could occur as acontinuous automated process. Then, a non-conductive material is mountedto the opposite side of the conductor, isolating the tracts electricallyfrom each other and from adjoining conductors. This could also occur asan automated process, and also nearly simultaneously to the cutting andfirst side application of the non-conductive material. Then, a foil ofconducting material, ideally aluminum, is applied to both the top andthe bottom of the enclosed conductor ribbon and joined at the edges tocreate an electrical shield. This action could also occur as anautomated process at a similar time to the cutting, and application ofthe non-conductive materials. Finally, a layer of insulating materialmay be applied over the shield, as needed. That material could consistof polymer, fabric or any flexible insulating material and could occuras part of an automated process.

In an alternative manufacturing process, strips of thin foil precut to adesired dimension, could be joined to a non-conductive surface insteadof cut foil. In addition, the shield material could be joined betweenconductor members to shield each conductor or set of conductorsindividually. In addition, a single sheet of foil could be placed aroundthe insulated conductive ribbon and joined to create a shield.

In another embodiment, fine wires arranged along the same plane andpositioned in contact with each other, or flat wire could be used as theconductors.

In another embodiment, the insulating material is a non-conductivepaintable or spray-on material such as the array of flat conductorscould be coated and then placed directly on the shield material.

In another embodiment, a pattern can be cut into the conductor foil suchthat the conductors turn corners for connections or to fit the contourof the housing into which it is placed. In a further embodiment, thewidth of the tracts could be varied based on the anticipated electricalsignal to be carried by the conductor. In a further embodiment, morethan one layer of divided foil conductors could be mounted on top ofeach other, preserving the relative homogeneity of the x-ray absorption.

In a further embodiment, connection between conductors within one foilor between foils would allow creation of electrical circuits where onconductive track is connected to another. The connection betweenconductors from one sheet to another can be accomplished though a foilconductor. One problem encountered when monitoring patients undergoingx-ray or MRI procedures is that the wires are visible to x-ray or theelectromagnetic field can induce heating or current within the wire.Carbon nanotubes or variants have been developed to provide electricalconnections in the environments. These conductors, however, and veryexpensive and provide poor shielding from electromagnetic fields. Inaddition, they tend to have poor conductivity, which is import when theconducted signal is of low power.

In yet another embodiment, the conductors may be printed in an array ona radiolucent insulative material, or both the radiolucent material andthe conductors may be printed in a manner that lays down the insulativelayers, conductive layers and shielding layers to prevent cross-talk andcreate a single wiring array construct.

One problem with reusable devices is contamination with biologicallyactive agents, such as bacteria, fungi, or viruses. One method to reducethe burden of biologically active material is application of certainfrequencies of photons, such as ultraviolet light. In this invention, amattress is described where a light source inside the mattress is usedto sterilize the mattress surface, by shining the light through a lighttransmitting cover.

In one embodiment, the light emitters are fiber optic strands woven intothe cover. The strands have a removal of the cladding at areas where themattress needs to be sterilized. In one embodiment, the cladding isremoved preferentially on the side to provide lateral photon dispersion,but no allow photons to escape to the mattress foam, which might bedamaging, or outside the mattress. In another embodiment, to limit theradial movement of the optical fibers and to improve durability, abundle of two or more fibers are contained in a jacket and woven into oradhered to the mattress. In another embodiment, the jacket around theoptical fibers allows differential photon passage, such that UV C lightcan be directed to the area that requires sterilization, but blocked toareas of the mattress that are sensitive to UV C or outside the mattresswhere it might damage bystanders.

UV C can be quite toxic to tissue and the present invention has anintegral sensor to determine if a person or object is on the mattress.Such a sensor can be a weight or distortion detector, such as apiezoelectric detector, a light based detector that measures surfacedistortion, an infrared detector that detects body heat, or a surfacelaser light device that detects the presence of an object on themattress surface. In another embodiment, a motion sensor is used todetect people in the room and to interrupt the photon emission. Themotion detector is attached to the mattress in one embodiment. Inanother embodiment, the motion detector is remote from the mattress andcommunicates wirelessly or by conductors. The motion detector can employany of a number of previously described methods, included sound or lightreflection.

Another means to sterilize the surface of patient mattresses is theapplication of intense heat for a short period of time, similar toPasteurization of dairy products. In this invention, the surface of themattress is loaded with resistive heating wires located close to eachother. With the application of current through the wires, the mattresssurface heat rapidly. When on or more thermistors located within themattress reach a pre-specified temperature, the current is reduced orinterrupted. As an alternative, a combination of temperature and timecould be used to signal that maximum effect had been achieved and effecta reduction or elimination of further heating.

In an alternative embodiment, the heating elements are attached to orlayered under a heat conductive cover. This cover can be composed of ametal, such as aluminum or a polymer, glass, or fabric loaded with aheat conductor. The heat source would provide heat energy and theconductor facilitates a more even spread of the heat. This reduces thepeak temperature and time needed to treat because the heterogeneity ofheat distribution is reduced.

Alternatively, other heat sources can be used, such as a heated fluid orair, and exothermic chemical reactions.

Safety measures similar to those described for use with UV Csterilization may also be employed to prevent the activation of the heatmattress disinfection when a patient or operator is in contact with themattress.

Determination of tissue oxygenation and blood flow has been describedand performed using a variety of methods, included pulsed oximetry andlaser Doppler methodology. Its application in a medical and non-medicalenvironments has allowed for monitoring of patients in hospitals andclinics, and for monitoring of sleep apnea and exercise performance.Monitoring requires the user to attach a sensor to the skin. The sensorsare usually handheld or fixed to the skin with adhesive.

In this embodiment, a sensor is mounted in a mattress or other devicethat people sit or lie on. The sensor sends and receives its signalthrough a transparent window in the device onto the subject body.

In a related device, the subject also wears a specialized clothing thatalso contains a window for transmission and reception of the signal,such that the signal can be transmitted through the mattress or otherdevice and then through the wearable clothing.

Another embodiment is aimed at preventing pressure sores and ulcersrelated to prolonged compression of skin and muscle while laying down orsitting. Lack of blood flow leads tissue ischemia and eventuallynecrosis. This embodiment includes a mattress containing a multitude ofsensors for oxygen concentration and/or tissue blood flow. The sensorsare located below the surface of the device, but send and receive theirsignal through the surface of the device in contact with the patient.The output from these sensors is displayed visually on a monitor. In oneembodiment, the display is a color or greyscale coded picture of thesupport structure, where the color or grey scale correspond to a rangeof values from the sensor. In further embodiment, a similar displayshows a calculated value derived from multiple patient values. Forexample, the product of blood flow and oxygen saturation. In anotherexample, a user or computer entered value such as the patient'shemoglobin concentration or body surface area, would be used in thecalculated value that is displayed. In another example, the calculatedvalue could result from a calculation of one or more user or computerentered values (such as height and weight), and one or more sensedvalves.

Patient undergoing medical procedures or surgical operations usually lieon a mattress or sit in a chair. They are frequently deeply sedated orcompletely unconscious for the procedure. The head is often instrumentedfor placement of sensors (such as EEG leads, temperature probes, andpulse-oximeter leads), control of respiration using an endotracheal orendonasal tube, and various devices that cannulate the stomach oresophagus (such as endoscopy catheters, trans-esophageal ultrasoundtransducers or nasogastric tubes). In some cases the head is covered bya sterile drape, making access to the head and communication with thepatient cumbersome. Moreover, the head is poorly supported, leadingphysicians to tape the head to the operating room table or mattress.

The invention described here is a molded head support that stabilizesthe head and neck, while at the same time providing a platform for themounting of sensors (such as EEG, temperature, pulse oximetry, ECG,video observation of the eyes and airways, exhaled CO2), attachment ofprobes and tubes (such as endotracheal tube, endoscopic devices,ultrasound devices, and tubing for medical gasses), and communicationwith the patient (speakers and microphone). The wires or fiberopticconnection to the sensors are passed through the head support. In oneembodiment, cables to external devices are attached to the head support.In another embodiment, the head support contains a radio transmitterthat transmits the sensor signal to the remote display device. Inanother embodiment, the head support is attached by a cable or opticalfiber to the mattress, operating table, or rail attached to theoperating table or mattress.

Therapeutic hypothermia has been used to improve the outcome of patientssuffering cardiac arrest or circulatory collapse. By slowing metabolismand oxygen consumption, organ salvage and survival is enhanced. Oneproblem is that cooling in the field has been difficult and cooling inthe hospital is often delayed by the time it takes to apply the coolingequipment. In addition, cooling of the brain, an essential organ veryvulnerable to hypoxia, is slowed by the skull, which is a heat sink. Oneembodiment includes a head apparatus with one or more thermistors tosense the cutaneous temperature of the skull. In addition, the body ofthe apparatus contains one or more cavities. The cavity(s) are connectedto a pressurized gas reservoir and an exhaust canal. A pressured valvecan be actuated, whereby the pressurized gas flows into the cavity(s)and due to the rapid pressure fall, the cavity is rapidly cooled.

In one embodiment, the thermistor(s) control the flow of gas to thecavity(s) individually or together by use of a feedback loop, wherebythe gas is controlled to achieve a set temperature. This will preventfreezing of the scalp while achieving maximal cooling. In anotherembodiment, a thermistor sensing core temperature would also providefeedback to the regular valve(s) to reduce flow when a set level of coreor brain temperature was achieved. Core temperature thermistors can belocated in the rectum, blood vessels, ear canal (as a tympanic membranesensor), and eyes (as a retinal temperature sensor, esophagus or otherlocations.

In another embodiment, the gas flow chambers could be perfused with achilled fluid, with similar controls by the thermistors feedbackloop(s).

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1—Image of the patient mattress showing the configuration of themattress components with a single arm board and radiation shieldinstalled.

FIG. 2—Image of the patient mattress with the inner comfort foamcomponent removed, revealing the rigid chest support component.

FIG. 3—Image of the patient mattress with both arm boards installed.

FIG. 4—Cross-sectional end view of the patient mattress demonstratingone embodiment of the component assembly.

FIG. 5—Cross-sectional end view of the patient mattress demonstratinganother embodiment of the component assembly that includes a hingedradiation shield.

FIG. 6—Alternate embodiment of the patient mattress describing a neckand waist radiation shield component.

FIG. 7—Image of an integrated induction coil used to power devicesplaced on the table.

FIG. 8—Image of an integrated induction coil as used in a sterile field.

FIG. 9—Image of the work table with magnet configurations used to holddevices within the sterile field.

FIG. 10—Cross-sectional end view of mattress demonstrating attachmentmechanisms used to connect radial table to patient mattress.

FIG. 11—Cross-sectional end view of mattress demonstrating attachmentmechanisms used to mount a rotatable radial table to patient mattress.

FIG. 12—Cross-sectional end view of mattress assembly demonstratingraised edges to prevent patient falls.

FIG. 13—Cross-sectional end view of mattress assembly demonstratingdeflectable raised edges that may be used to aid in patient transfer.

FIG. 14—Image of a deformable clip that can be used to hold guidewiresor catheters in a steady position on the table.

FIG. 15—Image of an alternate embodiment of a clip that uses amechanical ratchet to hold the clip closed on a guidewire or catheter onthe table.

FIG. 16—Image of an alternate embodiment of a clip that uses a ball andsocket attachment mechanism in conjunction with a magnet to mount to thepatient mattress or work table.

FIG. 17—Image of an alternate embodiment of a clip that uses acompressible block with retention clips to hold a guidewire or catheteron the table.

FIG. 18—Image of an alternate embodiment of a clip that uses acompressible block with retention clips to hold a guidewire or catheteron the table, shown open over a guidewire.

FIG. 19—Image of an alternate embodiment of a clip that uses acompressible block with retention clips to hold a guidewire or catheteron the table, shown closed upon a guidewire.

FIG. 20—Image of an integrated blood pressure cuff on the arm board ortable.

FIG. 21—Image of an integrated blood pressure cuff with tubingconnection on the arm board or table.

FIG. 22—End view image of a blood pressure cuff open, closed andinflated.

FIG. 23—End view image of a blood pressure cuff during use.

FIG. 24—Top view of the patient mattress with blood pressure cuffpositions described in serial fashion.

FIG. 25—Top view of the patient mattress with blood pressure cuffpositions described in parallel fashion.

FIG. 26—Image of a mattress with electrically conductive regions orconductors for ECG use.

FIG. 27—Image of a rail configuration around the perimeter of thepatient mattress.

FIG. 28—Image of an alternate rail configuration around portions of theperimeter of the patient mattress.

FIG. 29—Cross-sectional view of the rail, demonstrating lines carryinggas, data and power.

FIG. 30—Cross-sectional view of the mattress, demonstrating alternaterail configurations.

FIG. 31—Image showing a top view of the mattress with rails, showingpower connections and isolation locations.

FIG. 32—Image showing a top view of the mattress with rails, showing arechargeable battery within the rail.

FIG. 33—Image showing a top view of the mattress with rails, showing arechargeable battery within the mattress.

FIG. 34—Image showing a top view of the mattress with rails, showing agas line connection to the rail.

FIG. 35—Image showing a top view of the mattress with rails, showing agas system integrated into the rail.

FIG. 36—Image showing a top view of the mattress with rails, showing agas system integrated into the mattress.

FIG. 37—Image showing a top view of the mattress with rails, showing adata and processing system integrated into the rail.

FIG. 38—Image showing a top view of the mattress with rails, showing adata and multi-processing system integrated into the rail.

FIG. 39—Image showing a top view of the mattress with rails, showing adata and processing system integrated into the rail with wirelesscommunication and a CPU integrated into the mattress.

FIG. 40—Image of a patient lying atop the mattress with radiationprotection rollers across the waist and groin. Removable cutouts areavailable for femoral access.

FIG. 41—Image of a patient lying atop the mattress with radiationprotection rollers across the waist and groin. Additional rollersprovide protection from radiation backscatter from the shoulders andarms.

FIG. 42—Image of the roller mechanism and housing.

FIG. 43—Image of the roller mechanism and housing, with an integratedgrid within the roller to provide for fluoroscopic landmarks.

FIG. 44—Image of a roller mechanism used to provide contacts for a12-lead ECG across the body of the patient.

FIG. 45—Image of the roller mechanism with the 12-lead ECG in contactwith the patient.

FIG. 46—First insulating layer of a flat wiring system.

FIG. 47—Second layer of flat wiring system, consisting of film shieldingto prevent electrical interference.

FIG. 48—Third layer of flat wiring system, consisting of a secondinsulating layer.

FIG. 49—Fourth layer of flat wiring system, consisting of flat ribbonwires from the point of ECG connection to the mattress to the point ofmonitor connection to the mattress.

FIG. 50—Fifth layer of flat wiring system, consisting of a thirdinsulating layer.

FIG. 51—Sixth layer of flat wiring system, consisting of additional flatribbon wires from the point of ECG connection to the mattress to thepoint of monitor connection to the mattress.

FIG. 52—Seventh layer of flat wiring system, consisting of a fourthinsulating layer.

FIG. 53—Eighth layer of flat wiring system, consisting of a second layerof film shielding to prevent electrical interference.

FIG. 54—Ninth layer of flat wiring system, consisting of a finalinsulating layer.

FIG. 55—Cross-sectional view of the wiring assembly, demonstrating therelative position of the layered components.

FIG. 56—Image showing the configuration and components of an integratedultraviolet C system for mattress disinfection.

FIG. 57—Image showing the configuration and components of an integratedheating system for mattress disinfection.

FIG. 58—Image demonstrating integrated pulse oximetry into the mattress.

FIG. 59—Image showing the head nest system for the mattress, containingspeakers and rails.

FIG. 60—Image showing pulse oximetry and EEG connections in the headnest system.

FIG. 61—Image showing audio, power and gas connections to the head nest,as well as venting pattern for head cooling.

FIG. 62—Image showing full head capture for direct EEG contact and moreventing exposure for head cooling.

FIG. 63—Image showing flag radiation protection system with regions ofdeflection.

FIG. 64—Image showing flag radiation protection system integrated intothe mattress system.

FIG. 65—Image showing workbench in relation to the mattress, patient andbackscattered radiation.

FIG. 66—Image showing workbench in relation to the mattress,demonstrating rotation and tilt features.

FIG. 67—Image showing features of the workbench to accommodate patientanatomy and aid in compression of vascular access sites.

FIG. 68—Image showing workbench with adjustability of width toaccommodate a range of vascular access sites.

FIG. 69—Image showing another embodiment of the flag, with articulatingvertical keys to provide radiation protection.

FIG. 70—Image showing overhead and side views of the keys relative tothe x-ray detector.

FIG. 71—Image showing mechanism that provides flexion of the rigid keysat the hinged base.

FIG. 72—Image showing integrated protection system to prevent keys frombeing damaged by contact from the x-ray detector.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

FIG. 1 describes the configuration of one embodiment of the mattress.There is a comfort foam component 2 housed within a relatively rigidouter shell 1. Under the torso of the patient is a more rigid component3 that may be used to support chest compressions. The ends of component3 may also be used to mount additional items to the mattress. In thisembodiment, removable arm boards 4 are designed to be placed on the endsof component 3. A radiation protection wing 5 may be mounted to the armboard 4 to prevent backscatter radiation from reaching the staff in thecardiac catheterization laboratory.

FIG. 2 shows the mattress shell 1 with the patient comfort component 2removed. This demonstrates the location and orientation of the rigidtorso component 3.

FIG. 3 shows the patient mattress with a second arm board 4 mounted tothe rigid component 3.

FIG. 4 shows a cross-sectional view of the mattress that demonstratesone embodiment of the component assembly. The patient comfort component2 resides within the rigid shell 1. The rigid torso component 3 crossesthrough the shell 1 and may be used to mount the arm board 4 to themattress assembly. The radiation protection wing 5 is mounted to the armboard 4 using the receiving slot 6, which holds the wing 5 in place witheither a friction fit or through the use of magnets or some otherengaging mechanism. Magnetically sensitive material or a magnet 7 on thearm board 4 can also be used to affix the arm board to the side of therigid shell 1 with a mating magnetic surface 8.

FIG. 5 shows a cross-sectional view of the mattress similar to that ofFIG. 4. In this case, the radiation protection wing 5 contains a springloaded hinge 9 that will aid in the flexion of the wing away from themattress if a component of a fluoroscopy unit comes into contact withit.

FIG. 6 shows additional components that are added to the mattress toprovide additional radiation protection. The neck protection component10 is placed near the head of the patient, and contains a neck cutout 12to provide for access to the jugular vein for interventional cardiologyprocedures. The waist protection component 11 is placed at the waist ofthe patient, and may contain a femoral cutout 13 to allow for access tothe femoral arteries or veins in the groin.

FIG. 7 shows an induction coil 15 that can be mounted to any workingsurface on the mattress, particularly the work table 14. The inductioncoil 15 is powered through an integrated cable 16.

FIG. 8 shows a similar image to that of FIG. 7. A device power source 17is placed on a sterile drape 49 over the induction coil 15. The systemis designed to power that device via a power cable 17 that is designedto be within the sterile field.

FIG. 9 demonstrates magnet patterns that may be used in conjunction withthe table 14. Individual magnets 19 may be embedded in or fixed to thetable 14. Magnetic bars 20 may also be used in a similar manner. Dipolemagnetic bars 21 may be also used to ensure correct orientation ofdevices with similar magnets that are affixed to the table 14. Thesemagnets are all designed to hold sterile components to the table 14through a sterile drape 49.

FIG. 10 describes mounting mechanisms to hold a work table 14 or radialboard 23 to the edge of the rigid shell 1. A rail 22 mounted to the edgeof the rigid shell 1 provides an attachment surface that can be used asan attachment point. A latch and release mechanism 24 can be used toreversibly attach the radial board 23 to the rail 22. The latch andrelease mechanism 24, along with the attachment surface of theguiderail, are constructed and arranged, in one embodiment, such thataccessories equipped with the latch and release mechanism, such as atable, arm rest, instrumentation, radiation shields, monitors, and otherequipment, may be easily attached to the guiderail and slid down thelength of the guiderail to an optimal position before being locked inplace. Additionally, a secondary support mechanism may be used toprovide additional support to carry loads on the radial board 23.

FIG. 11 describes a similar configuration to that of FIG. 10, with theaddition of a hinge mechanism 27 which allows for the radial board 23 tobe rotated downward for stowing when not in use. The hinge mechanism 27is activated by pressing or pulling the release mechanism 26.

FIG. 12 demonstrates a mattress configuration to aid in patient transferand to prevent inadvertent patient falls from bed. The rigid shell 1 hasraised edges 28 and 29 that will resist a patient fall. These edges maybe of flexible material and be able to flex out of the way, or be morerigid and have a parting line 30 where the material can more easilydisplace.

FIG. 13 describes a similar configuration to that of FIG. 12, with theaddition of a locking mechanism 31 that can be used to hold thedisplaced edge of the rigid shell 1 during patient transfer. Thislocking mechanism 31 holds the edge 29 in a lateral position tofacilitate sliding a patient onto or off of the mattress 2 from agurney.

FIG. 14 describes one embodiment of a clip used to aid in holdingguidewires or catheters during interventional procedures. The body ofthe clip 33 is an elastomer that is partially split. The gap 50 createdby the split and the slit 51 may be used to hold a guidewire or catheter54 in a defined position. A magnetic base 32 is affixed to one surfaceof the clip to allow the clip to be reversibly attached to a worksurface beneath a sterile drape within the sterile field of acatheterization procedure.

Another embodiment of a clip mechanism is shown in FIG. 15. In thisembodiment, a first half 35 and a second half 36 are mounted to amagnetic base 32. Embedded in or attached to each half is a supportingpost 37 that is mounted to the base 32. This mounting mechanism mayinclude a hinge 38, or the posts may be of a flexible material thatallow for bending. A ratchet mechanism 39 bridges the gap between thefirst half 35 and the second half 36. A guidewire or catheter 34 may beplaced within the gap 50 between the first half 35 and the second half36. When the first half 35 and the second half 36 are pressed towardsone another, the ratchet mechanism 39 engages, holding the halvestogether and holding the position of the catheter or guidewire 34.

In yet another embodiment of a clip mechanism shown in FIG. 16, asecondary attachment mechanism may be used to supplement or replace themagnetic base 32 of the clip. A post containing a ball 40 may be mountedbelow the magnetic base 32. This ball 40 can be reversibly inserted intoa receiving cup 42 on a work surface 41. This construct allows forrotation of the entire clip assembly 52, to better align the clip to acatheter or to manipulate the position of the holder during use.

FIG. 17 describes another embodiment of a clip mechanism. A compressibleblock 43 contains a slit 45 for receiving a guidewire or catheter 34.Two lever arms 44 and 53 are mounted to the sides of the compressibleblock 43 that each have a clip lock edge 47 for engagement with thetapered block surface 46. The lever arms contain cutouts to allow forthe guidewire or catheter 34 to sit in the bottom of the slit 45.

FIG. 18 shows the guidewire or catheter 34 placed within the slit 45,prior to engagement of the lever arm clips.

FIG. 19 shows the engagement of the compressive block 43 on theguidewire or catheter 34. The ends of the compressible block 43 aresqueezed towards one another, enabling the clip lock edge 47 of thelever arms 44 and 53 to slide along the tapered surface of thecompressible block 43. When the clip lock edges 47 extend beyond the endof the compressible block 43, the clip lock edges latch onto the end ofthe compressible block and hold it in a compressed position. Thiscompression engages the guidewire or catheter 34 and maintains it in afixed position. To disengage the clip from the guidewire or catheter 34,the ends of the lever arms 44 and 53 are squeezed towards one another,releasing the clip lock edges 47 from the end of the compressible block43 and opening the slit 45.

FIG. 20 shows a blood pressure cuff 68 designed to be added as acomponent to the patient mattress. The outer shell 60 of the cuff ismounted to the table or arm board 65, and contains a hinge 61 thatallows the outer shell 60 to open and close at the parting line 62 in aclamshell fashion to allow the arm of the patient to be inserted withoutnecessitating sliding the device over the hand and arm of the patient.Clasps or magnetic attachments 63 located at the part line 62 hold theouter shell 60 closed after arm insertion. The air bladder 64 isretained within the outer shell 60.

FIG. 21 shows a side view of the blood pressure cuff 68, with the outershell 60 mounted to the arm board 65. Blood pressure air tubing 66 isrun along the surface of the arm board 65 or embedded within, leadingfrom the outer shell 60 to a tubing connection 67 integrated into thearm board 65.

FIG. 22 demonstrates how the blood pressure cuff 68 is used. The outershell 60 opens in a clamshell fashion about the hinge 61. Once the armof the patient is inserted into the clamshell, the outer shell 60 isclosed and the opposite surfaces of the parting line 62 are affixed toone another with clasps or magnetic attachments 63. Once closed andlocked, the air bladder 64 may be inflated in order to obtain patientblood pressure.

FIG. 23 demonstrates the measurement of blood pressure during the use ofthe blood pressure cuff 68. When the air bladder 64 is inflated fully,blood flow through the arm is stopped. As the pressure in the airbladder 64 drops below systolic blood pressure, blood flow will begin inan intermittent fashion. The air pressure in the system is then equatedto peak systolic pressure. As the air pressure continues to drop, theair pressure in the air bladder 64 drops below diastolic pressure andcontinuous blood flow is observed. This air pressure in the system isequated to diastolic pressure.

FIG. 24 demonstrates where these blood pressure cuffs 68 may beintegrated into the mattress. Air tubing 70 is integrated into themattress 69, leading from a junction box 72 that connects to the pumpand sensor to the valved receptacle 71 used for connecting the bloodpressure cuff 68. These blood pressure cuffs 68 are connected to thereceptacle 71 using air tubing 66. Locations of the cuff may be placedsuch that they can be used for either arm or either leg.

FIG. 25 demonstrates how the integrated blood pressure cuffs 68 can becontrolled to ensure that pressure is being read from an activelocation. A pressure sensing control can be integrated into theintegrated air tubing 70 such that the junction box 72 will pick uppressure oscillations and open the junction valve to the active tube.Alternately, a conductor 73 may be used at each local connectionreceptacle 71 to communicate with the junction box 72 that a connectionto a pressure cuff tube 66 has been made, activating that pressure line70.

FIG. 26 shows electrically conductive components integrated into themattress. The electrodes 81 are embedded into the surface of themattress 69 with conductive wires 83 running to a junction box 84 forconnection to a monitoring system. A drape 80 is placed over themattress 69, with the drape containing electrically conductive regions82 through which the electrical connection from the patient to theelectrodes 81 may be made. In order to ensure alignment of theconductive regions 82 to the electrodes 81, reference markers 86 areplaced at the edges to match up with markers on the mattress 69.Additional reference markers 85 on the drape 80 show the areas where theelectrodes 81 are placed, to ensure proper patient positioning.

FIG. 27 demonstrates one embodiment of the patient mattress 69 in whichthe integrated rails 111 extend the length of the mattress 69 alongeither side. The wing 5 is attached with the arm board 4 to the rail 111on the right side of the patient 150. The waist radiation protectioncomponent is in the form of a flag 100 that is mounted to the rail 111on the patient left side. A patient workbench 250 is also mounted to therail 111 on the patient left side and resides across the waist and groinarea of the patient 150.

FIG. 28 demonstrates an alternate embodiment of the patient mattress 69in which integrated rails 111 are mounted to the sides and end of theouter shell 1.

FIG. 29 shows a cross-sectional view of the rails 111 integrated withthe outer shell 1 via a rigid connector 112. Within the rail 111 and theconnector 112 resides a gas line 113 that terminates at a regulator 114which can communicate with tubing to the patient. Also housed within therail 111 and connector 112 is a power line 117 that comes from withinthe outer shell 1 and terminates in a power connection 118 that may beused to power devices for patient monitoring or care. The rail 111 alsohouses a data line 115 that terminates in a data connector 116 that canbe used to transfer data to and from the patient.

FIG. 30 describes methods in which the rail 111 may be mounted relativeto the mattress 69. The rail 111 may be mounted to the outer shell 1 viarail supports 112 that affix to the outer shell 1, with the rail 111recessed within the body of the outer shell 1. There may also be alateral support 107 that traverses between rails 111 on either side ofthe outer shell 1. Alternately, the rail 111 may have a secondarysupport 106 to the outer shell 1, and may also have a rigid member 108along the inner perimeter of the outer shell 1 that connects the tworails 111 together. Finally, as shown in this figure the rail 111 may ormay not be recessed into the outer shell 1.

FIG. 31 details a power system that is integrated into the rail 111. Therail 111 is affixed to the outer shell 1 of the mattress system 69 byrail supports 112. Attached to the rail 111 is a power connection 109 toan outside source. Within the rail 111 is a power isolation andconditioner 110 that is used for voltage, polarity or transforming fromalternating to direct current. A power line 117 runs through the railsystem and power outlet connections 118 are placed in areas of needalong the perimeter of the mattress 69 within the rail system 111.

FIG. 32 describes a power system similar to that of FIG. 31, with aninternal power supply. A rechargeable/replaceable battery 136 isintegrated into the rail in place of the external power connection 109,allowing the mattress system more portability.

FIG. 33 describes a portable power system similar to that of FIG. 32,but with a battery 119 that is housed within the inner comfort component2 of the mattress system 69. A detachable charging cable 120 can providefor the ability to recharge the battery 119 when necessary.

FIG. 34 describes how the rail system 111 can be used to transfer gas tothe patient. Gas from an outside source is connected to the rail via theconnector 121 and a gas regulator 122 is integrated into the rail 111. Agas line 123 runs through the rail 111 and gas output valves 124 areplaced in areas of need along the perimeter of the mattress system 69.

FIG. 35 describes a gas system similar to that of FIG. 34, but with thegas supply housed within or attached to the rail 111 itself. A gassource 125 is mounted within or on the rail 111, with a gas regulator122 used to manage gas pressure and flow.

FIG. 36 describes a gas system similar to that of FIG. 35, but with thegas source 125 housed within the inner comfort component 2 of themattress system 69.

FIG. 37 describes how the rail system 111 may be used to carry data. Adata connection 126 from an outside source is connected to the rail 111,and a data processing CPU (physiologic monitor, connection to hospitalIT or a device controller) is housed within the rail. A data line 128runs through the rail system 111, and data outlet connections 129 areplaced in areas of need around the perimeter of the mattress system 69.

FIG. 38 describes a rail data and processing system with data isolation,multiple processors and a user interface integrated into the rail. Datais connected from an outside source 126, where an electrical isolation130 and a data processing CPU 127 are mounted. Data is carried throughthe rail 111 via a data line 128, and data outlet connections 129 aremounted within the rail at locations where needed. A user interface 132is mounted where accessible by the health care staff, and a second CPU131 may also be integrated into the rail to provide additional computingpower. In addition, devices may communicate with each other directlythought the rail data line. In addition, the user may control devices onthe rail data system or send commands to elements connected to the dataline 126 through user interface 132.

FIG. 39 describes a system similar to that of FIG. 38, with an alternateembodiment in which the CPU 134 is mounted within the patient comfortcomponent of the mattress 2, and connected to the rail via a data line135. The data communication to the outside in this embodiment is in theform of a wireless data transmitter and receiver 133.

FIG. 40 shows a system of radiation protection integrated into themattress system 69. A sheet of radiation protective material 155 isdraped across a subject 150 lying on the mattress 69. This radiationprotective material 155 is housed within a roller 154 when not in use.It is affixed across the table using a connector 151, which may be ahook or a magnetic attachment. Sites for femoral vessel access areplaced in the radiation protective sheet 155 at the location of the leftfemoral 152 and the right femoral 153 arteries and veins. Access sitesthat are not used for a procedure may be closed off to prevent radiationbackscatter from emitting through the access sites.

FIG. 41 shows a system of radiation protection similar to that of FIG.40, with additional radiation backscatter protection provided by rollersheets of radiation protection material 155 draped over the shoulders ofthe subject 150 from rollers 156 mounted at the head of the mattresssystem 69. These may be held in place by weighted pads or magnets 168integrated into the end of the radiation protection material 155. Inaddition the shoulder radiation protection sheet may be attached to thefemoral roller sheet 155 using hooks, clasps, zippers or magnets.

FIG. 42 shows one embodiment of the roller 154 in which the radiationprotection material 155 is stored within a container of sterilizationfluid 159 to prevent bacterial or viral contamination from being passedfrom patient to patient.

FIG. 43 shows an embodiment of the roller 154 in which the radiationprotective material 155 also contains a grid and dot marker matrix 159on the sheets which are visible using fluoroscopy so that the grid maybe used for reference location or measurement.

FIG. 44 shows an embodiment of a roller system 154 in which the materialon the roller is not radiation protective 155, but rather anelectrically conductive film array 169. The subject on the mattress 150has conductive patches 160 placed for an ECG in the areas of interest.As the roller material is draped across the subject on the mattress 150and connected to the far side of the table 151, the conductive patches160 come in contact with the conductive film array 169. The systemsenses which areas of the array are receiving an active signal and thatdata is sent to create the ECG. In another embodiment, the roller shieldis both electrically conductive and provides radiation protection.

FIG. 45 provides an additional embodiment of the ECG construct. An ECGprocessing unit 166 is mounted to the mattress 69. The conductive filmarray 169 communicates with the processing unit 166. Conductive patches162 that are not in contact with the conductive array film are connectedwith the processing unit 166 with traditional leads 165.

FIG. 46 describes the first layer of a flat wiring system for use in afluoroscopic field. This layer is an insulator 175, preventingelectrical contact with adjacent materials. In one embodiment it is apolymeric film. It is shaped to fit the inner surfaces of the outershell 1 of the mattress system.

FIG. 47 describes the second layer of a flat wiring system. This layeris electrical shielding 176, in one embodiment being composed ofaluminum film.

FIG. 48 describes the third layer of a flat wiring system. This layer isan insulator 175, preventing contact between the shielding and theconductors.

FIG. 49 describes fourth layer of a flat wiring system, including thehead side ECG leads. The left 177, center 178 and right 179 leads layatop the insulator 175 and do not come into contact with each other.

FIG. 50 describes the fifth layer of a flat wiring system. This layer isan insulator 175, preventing contact between the lead layers.

FIG. 51 describes the sixth layer of a flat wiring system. This layercontains additional chest leads and arm/leg leads. These leads do notcome into contact with each other and terminate at ECG locations withinthe mattress shell 1.

FIG. 52 describes the seventh layer of a flat wiring system. This layeris an insulator 175, preventing contact between the conductors andshielding.

FIG. 53 describes the eighth layer of a flat wiring system. This layeris electrical shielding 176, in one embodiment being composed ofaluminum film.

FIG. 54 describes the ninth layer of a flat wiring system. This layer isan insulator 175, preventing contact between the shielding and adjacentmaterials.

FIG. 55 is a cross-sectional end view of the flat wiring system, showingthe relative positions of the insulation 175, shielding 176 and ECGleads 177-184.

FIG. 56 describes a system for integrating UV C sterilization into thepatient mattress system 69. In one embodiment, optical fibers 190 areinterwoven or embedded into the mattress surface with a removable lightshield 191 used as one means to protect the health care workers from UVexposure. In another embodiment, the optical fibers are cladded with ashielding material 192, which is partially removed from the fiber inorder to provide directional shielding from the UV rays.

FIG. 57 describes a system for integrating heat sterilization into thepatient mattress system 69. Heating elements 195 are integrated into thesurface of the mattress and a heat conductor 196 diffuses the heatthroughout the mattress surface. Heat sensors 197 are used to ensurethat the heat is sufficient for sterilization, and provide a safetymechanism to prevent activation of the heating system if a patient is onthe mattress system 69.

FIG. 58 describes a system for integrating pulse oximetry into thepatient mattress system 69. Pulse oximetry emitter-detectors 200 areplaced within the mattress and the mattress system 69 is draped with aclear drape 202. Light 201 is emitted by the emitter-detectors 200through the clear drape 202 to the skin of the patient and the responsepicked up by the emitter-detector 200 is used to determine blood oxygencontent. In an alternate embodiment, the emitter-detectors 200 emitcoherent light where changes in reflected light frequency are used todetect tissue blood flow.

FIG. 59 describes a head component 210 to be used with the mattresssystem 69. This is intended as a type of pillow, with additionalfunctionality for the health care environment. In one embodiment, thishead component 210 contains speakers 212 and a microphone 213 forcommunication between the patient and the health care staff. The headcomponent 210 also has rails 211 affixed to it, to allow for mounting ofequipment (EEG, camera, pulse oximetry) near the head of the patient.

FIG. 60 describes further features of the head component 210. There areEEG lead connection sites for input 216 and output 217, as well as pulseoximetry input 214 and output 215 locations.

FIG. 61 describes a further embodiment of the head component 210. Thereare locations for audio in and out 221 as well as a power supply 222.Additionally, the head component 210 may be used for hypothermic headcooling, in which gas can be connected to the head component 210 via agas connector 224, and cooling gas may be driven through vent holes 223to cool the scalp. Temperature sensors 225 on the head component may beused to automatically drive gas flow until the scalp reaches a preferredtemperature.

Alternately, as shown in FIG. 62 the head component 210 may fullyencapsulate the head, using a scalp component 219 that can providedirect EEG contact, as well as a modular neck component 220 that canrestrain the head. This fully encapsulated system can provide moresurface for the cooling vents 223 as well.

FIG. 63 describes a radiation protection flag designed to reside overthe patient, positioned across the width of the table. The lower unit231 is relatively rigid, with a cutout for the patient anatomy 233, inthis case the groin for femoral vascular access. The upper unit 230 isattached to the lower unit 231 by a hinge mechanism 234 that allows thetop of the upper unit 230 to flex or rotate towards the head 236 ortowards the feet 235 of the patient relative to the lower unit 231. Alateral unit 232 that may be made as a solitary component or with upperand lower units is attached to the rest of the flag by a vertical hinge238 that allows for rotation of the outer edge towards the head or feetof the patient. A cutout 237 in the bottom of the lateral unit 232accommodates the arm of the patient for radial vascular access.

FIG. 64 shows the radiation protection flag in position on the patientmattress 69. The lateral unit 232 sits over the right arm of the patient150, with the cutout 233 residing over the patient waist or groin. Thevertical hinge 238 allows for flexion of the lateral unit 232 to betterwrap around the patient 150 and to provide more complete radiationprotection.

FIG. 65 shows a perspective end view of the workbench 250 over thepatient 150 on the mattress 69. The workbench 250 is radiationprotective to prevent x-ray photons 251 from backscattering from thepatient out to the health care staff. The workbench is mounted to therail 111 using a vertical connection mechanism 252 by which the devicemay be reversibly affixed. The workbench is designed to provide multipledegrees of freedom in order to allow adjustments for height, rotationand tilt.

FIG. 66 shows top 256 and side 255 views of the workbench. In the sideview 255, the workbench 250 can be rotated 253 about the vertical post252. In the top view 256, cutouts 257 in the workbench 250 for femoralvessel access are shown. This workbench 250 is connected to the rails111 in such a way that the workbench 250 may be rotated 253 over thepatient 150 away from the operator 254 in order to gain access to thepatient 150 or to facilitate patient transfer to or from the mattress69.

FIG. 67 demonstrates side views 259 of the workbench 250 with acompression feature 258 to apply pressure to the patient (for example,to stop bleeding). When deflated, the compression feature 258 does notcome into contact with the patient 150. When inflated, the compressionfeature 258 comes into contact with the patient, with the workbench 250supporting the compression feature 258 such that active compression isplaced on the leg of the patient. This compression may be used toprevent blood loss through a vascular access site after removal ofcatheters.

FIG. 68 demonstrates a feature in which the workbench 250 may beexpanded in size to change the relative positions of the femoral accesscutouts 257 for various sized patients. In one embodiment, lateralworkbench components 259 and 260 may be extended or retracted relativeto a center component 261 in order to create a wide configuration 262 ora narrow configuration 263.

FIG. 69 demonstrates an embodiment of the flag 280 in which theradiation protection component of the flag is constructed of a series ofrigid components or keys 281 that interlock and interact with oneanother. These keys 281 may be constructed of transparent material,opaque material or a combination of the two. Many of the keys have anelement of transparent radiopaque glass 282 and an adjacent element ofvisually and radiation opaque material 283 rigidly attached to oneanother. These keys 281 are each attached to a lateral bar 284 by ahinge 285 that allows for rotational motion of the keys 218 about theaxis of the lateral bar 284. The system contains a swivel 286 thatallows the flag 280 to rotate about a vertical support bar 287. At thepatient right arm side, there is a hinge 288 that allows for rotationabout a vertical axis to adjust the shape of the flag 280. There areoverlapping rigid plates 289 with a cutout for the patient arm 290 thatallows for height adjustment. Below the lateral bar 284 there areelements of flexible radiopaque material 291 that allow for theshielding to accommodate the shape of the patient. There are alsoadditional swivel elements 292 and 293 that provide for additionaldegrees of freedom, allowing rotation in horizontal and vertical planesrespectively.

FIG. 70 demonstrates how the flag embodiment 280 performs during use.The vertical hinge 288 allows the most lateral keys 281 of the flag tobe flexed to accommodate the table and patient anatomy while continuingto provide good radiation protection to the health care staff. When thex-ray system 295 is advanced into contact with the flag 280, the keys ofthe flag 281 which are contacted by the x-ray system 295 flex about alateral hinge 285, deflecting the key 281 which can consist of aradiopaque translucent component 282 and a radiopaque and visuallyopaque component 283.

FIG. 71 describes the assembly details of one embodiment of theradiopaque key mechanism. The transparent radiopaque material 282 may bea leaded glass with a thickness of about 7 mm. This leaded glass ishoused in a perimeter casing 300 of a polymer or other structurallyprotective material. A liner material 391 resides under the glass at thebase of the key 281 to protect the glass from vibration or impact. Thehinge 285 is mounted to the lateral arm 284 using a set screw mechanism302. This hinge 285 is mounted to the glass casing 300 with a hinge hasp303 that is bolted through the glass 282 into a receiving plate 304. Theglass 282 is protected from the bolt 305 by a bearing sleeve 306 and anylon spacer 307.

FIG. 72 describes some detail as to the construction of thetransparent/opaque assembly of the key 281. A front view 310 of theassembly shows the glass 282 and the opaque component 283 housed withina protective outer shell 300. A side view 309 of the assembly shows howan inner layer of radiopaque material 311 can be sandwiched withinlayers of a lightweight filler material 312 to create an assembly ofconstant thickness.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A mattress comprising: a soft comfort componentthat complies with a patient's body when the patient is lying on themattress; a shell surrounding at least a lower surface of the comfortcomponent and integral therewith, said shell being more rigid than thesoft comfort component; a plurality of radiation shields placed toseparate an operator from an imaging device, at least one of saidplurality of radiation shields being flexible and connected to saidmattress at a connected edge and configured with a free edge oppositethe connected edge such that said flexible radiation shield will flexout of the way when contacted by the imaging device, wherein one of theplurality of shields is a workbench having sliding surfaces that allowdimensions of the workbench to be adjustable to fit different patientsizes; and, a guiderail system attached to the shell, the guiderailsystem including a guiderail providing an attachment surface usable toattach accessories to said guiderail.
 2. The mattress of claim 1 whereinsaid shell surrounds a lower surface and at least a portion of at leastone side surface of said soft comfort component.
 3. The mattress ofclaim 1 wherein said soft comfort component includes a chest portion ofincreased stiffness to facilitate chest support during application ofresuscitative chest compressions.
 4. The mattress of claim 1 whereinsaid guiderail system further includes electrical lines integrated intosaid guiderails.
 5. The mattress of claim 1 wherein said guiderailsystem further includes data lines integrated into said guiderails. 6.The mattress of claim 1 wherein said guiderail system further includesgas lines integrated into said guiderails.
 7. A mattress system for usein a hospital comprising: a mattress comprising: a soft comfortcomponent that complies with a patient's body when the patient is lyingon the mattress; a shell surrounding at least a lower surface of thecomfort component and integral therewith, said shell being more rigidthan the soft comfort component; a plurality of radiation shields placedto separate an operator from an imaging device, at least one of saidplurality of radiation shields being flexible and connected to saidmattress at a connected edge and configured with a free edge oppositethe connected edge such that said flexible radiation shield will flexout of the way when contacted by the imaging device; a guiderail systemattached to the shell, the guiderail system including a guiderailproviding an attachment surface usable to attach accessories to saidguiderail; and, a radiation-shielding workbench having sliding surfacesthat allow dimensions of the workbench to be adjustable to fit differentpatient sizes; and, a latch and release mechanism slidably attachable tosaid guiderail such that, once attached to said guiderail, saidcomponent may be slid along said attachment surface to a desiredlocation.
 8. The mattress system of claim 7 wherein said shell surroundsa lower surface and at least a portion of at least one side surface ofsaid soft comfort component.
 9. The mattress system of claim 7 whereinsaid soft comfort component includes a chest portion of increasedstiffness to facilitate chest support during application ofresuscitative chest compressions.
 10. The mattress system of claim 7wherein said guiderail system further includes electrical linesintegrated into said guiderails.
 11. The mattress system of claim 7wherein said guiderail system further includes data lines integratedinto said guiderails.
 12. The mattress system of claim 7 wherein saidguiderail system further includes gas lines integrated into saidguiderails.
 13. The mattress system of claim 7 wherein said radiationshield includes a lateral unit that extends vertically from said latchand release mechanism when said latch and release mechanism is attachedto said guiderail.
 14. The mattress system of claim 13 wherein saidradiation shield further includes an upper unit and a lower unitattached to said upper unit, wherein at least one of said upper andlower units are attached to said lateral unit.
 15. The mattress systemof claim 14 wherein said upper unit pivots vertically about said lowerunit.
 16. The mattress system of claim 15 wherein said upper unitincludes vertical keys, thereby forming a plurality of vertical segmentsthat may be positioned angled relative to each other.